AdaptResponse Clinical Trial

NCT02205359 | Completed Results DMC

• 1 other identifier: AdaptResponse
• Study Type: interventional
• Target: 3,797
• Locations: 27 countries
• Sites: 218

Brief Summary

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

Conditions

Heart Failure With Left Bundle Branch Block

Keywords

AdaptivCRT; aCRT

Outcome Measures

Primary Outcomes (1)

• Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation

  The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).

  from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)

Secondary Outcomes (7)

• All-cause Mortality

  from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)

• Percent of Patients With Interventions for Heart Failure Decompensation

  from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)

• Clinical Composite Score

  CCS at 6 month post randomization

• Atrial Fibrillation

  from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)

• Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  from baseline to 24M follow up

Study Arms (2)

aCRT ON

EXPERIMENTAL

The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise

Device: aCRT ON

aCRT OFF

ACTIVE COMPARATOR

Standard CRT

Device: aCRT OFF

Interventions

aCRT ON DEVICE

CRT device with AdaptivCRT enabled (AdaptivBiV and LV)

aCRT ON

aCRT OFF DEVICE

CRT device with AdaptivCRT disabled

aCRT OFF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is willing to sign and date the study Patient Informed Consent Form.
• Subject is indicated for a CRT device according to local guidelines.
• Sinus Rhythm at time of enrollment
• Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
• Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
• Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
• NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.

You may not qualify if:

• Subject is less than 18 years of age (or has not reached minimum age per local law).
• Subject is not expected to remain available for at least 2 years of follow-up visits.
• Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
• Subject is, or previously has been, receiving cardiac resynchronization therapy.
• Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
• Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
• Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
• Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
• Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
• Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (220)

CardioVascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Phoenix Cardiovascular Research Group, LLC

Phoenix, Arizona, 85018-3956, United States

Location

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas, 72205-6202, United States

Location

Scripps Green Hospital Scripps Clinic Torrey Pines

La Jolla, California, 92037-1027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048-5913, United States

Location

Coggins & Levy Medical Associates

San Jose, California, 95124, United States

Location

Stanford Hospital & Clinics

Stanford, California, 94305-2200, United States

Location

Saint Joseph's Medical Center

Stockton, California, 95204, United States

Location

Penrose Hospital

Colorado Springs, Colorado, 80907-6863, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80528, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06606-4284, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010-3017, United States

Location

Heart & Vascular Institute of Florida

Clearwater, Florida, 33756-3367, United States

Location

Florida Heart Rhythm Specialists PLLC

Fort Lauderdale, Florida, 33308, United States

Location

The Cardiac & Vascular Institute

Gainesville, Florida, United States

Location

First Coast Cardiovascular Institute PA

Jacksonville, Florida, 32256-6954, United States

Location

Cardiovascular Research Center of South Florida

Miami, Florida, United States

Location

AdventHealth Cardiovascular Research Institute

Orlando, Florida, 32803-1248, United States

Location

Cardiology Institute of Northwest Florida

Panama City, Florida, 32401-3665, United States

Location

University of South Florida Health (USF)

Tampa, Florida, 33606, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308-2225, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, United States

Location

Northwerstern University

Chicago, Illinois, 60611, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62769-0002, United States

Location

Saint Francis Medical Group Indiana Heart Physician

Indianapolis, Indiana, 46237-6345, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121-2429, United States

Location

MedStar Health Research Institute

Baltimore, Maryland, 21237-3958, United States

Location

Massachusetts General Hospital (Boston MA)

Boston, Massachusetts, 02114-2621, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5853, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

William Beaumont Hospital

Troy, Michigan, 48098-6375, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197-8633, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

North Memorial Heart and Vascular Institute

Robbinsdale, Minnesota, 55422-2926, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102-2568, United States

Location

Mid America Heart Institute (MAHI)

Kansas City, Missouri, 64132, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Glacier View Research Institute Cardiology

Kalispell, Montana, 59901, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043-4322, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106-4921, United States

Location

New York Methodist Hospital

Brooklyn, New York, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Location

NYU Langone Medical Center

New York, New York, United States

Location

Weill Medical College of Cornell University

New York, New York, United States

Location

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, United States

Location

Central New York Cardiology

Utica, New York, United States

Location

Asheville Cardiology Associate PA

Asheville, North Carolina, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27705, United States

Location

Wake Forest Baptist Health High Point Medical Center

High Point, North Carolina, United States

Location

Raleigh Cardiology Associates

Raleigh, North Carolina, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, United States

Location

The Lindner Research Center

Cincinnati, Ohio, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Mount Carmel East

Columbus, Ohio, United States

Location

The Ohio State University

Columbus, Ohio, United States

Location

North Ohio Heart-Elyria

Elyria, Ohio, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, United States

Location

Sacred Heart Medical Center

Eugene, Oregon, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Location

Capital Area Research

Camp Hill, Pennsylvania, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Mercer Bucks Cardiology

Newtown, Pennsylvania, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Location

Great Valley Cardiology

Scranton, Pennsylvania, 18510, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Location

Sutherland Cardiology Clinic

Memphis, Tennessee, United States

Location

Centennial Heart Cardiovascular Consultants LLC

Nashville, Tennessee, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Location

The University of Texas (UT) Southwestern Medical Center

Dallas, Texas, United States

Location

CHI St. Luke's Heath Baylor College of Medicine Medical Center

Houston, Texas, United States

Location

Baylor Research Institute

Plano, Texas, 75093, United States

Location

EP Heart LLC

The Woodlands, Texas, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Location

University of Utah

Salt Lake City, Utah, United States

Location

The University of Vermont Medical Center Inc

Burlington, Vermont, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Location

Virginia Cardiovascular Specialists PC

Richmond, Virginia, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Location

Swedish Medical Center Cherry Hill

Seattle, Washington, United States

Location

Providence Spokane Cardiology

Spokane, Washington, United States

Location

CAMC Health Education & Research Institute Inc

Charleston, West Virginia, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53211, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

John Hunter Hospital

New Lambton, New South Wales, Australia

Location

Austin Hospital

Heidelberg, Victoria, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Location

Saint Vincent's Hospital (Sydney)

Sydney, Australia

Location

Landeskrankenhaus Innsbruck - Universitätskliniken

Innsbruck, Austria

Location

Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Location

AZ Sint-Jan Brugge-Oostende av

Bruges, Belgium

Location

Ziekenhuis Oost Limburg - Campus St.-Jan

Genk, Belgium

Location

London Health Sciences Centre - University Campus

London, Canada

Location

McGill Universtiy Health Centre (MUHC)

Montreal, Canada

Location

Southlake Regional Health Centre

Newmarket, Canada

Location

University of Ottawa Heart Institute

Ottawa, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Canada

Location

Royal Columbian Hospital

Vancouver, Canada

Location

Vancouver General Hospital

Vancouver, Canada

Location

Odense Universitetshospital

Odense C, 5000, Denmark

Location

Keski-Suomen Keskussairaala

Jyväskylä, Finland

Location

Satakunnan keskussairaala

Pori, Finland

Location

Centre Hospitalier Universitaire de Amiens - Hôpital SU

Amiens, France

Location

CHRU Tours - Hôpital Trousseau

Chambray-lès-Tours, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

CHRU La Rochelle

La Rochelle, 17019, France

Location

Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

La Tronche, France

Location

CHRU de Lille

Lille, France

Location

groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert

Lomme, France

Location

Hopital prive Clairval - Ramsay Sante

Marseille, France

Location

Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille

Marseille, France

Location

Institut Hospitalier Jacques Cartier

Massy, France

Location

CHR Metz-Thionville Hôpital de Mercy

Metz, France

Location

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

CMC-Clinique Ambroise Pare

Neuilly-sur-Seine, France

Location

Hôpital Pontchaillou - CHU de Rennes

Rennes, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Location

Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg

Bernau bei Berlin, Germany

Location

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bochum, Germany

Location

MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

Chemnitz, Germany

Location

Klinikum Coburg GmbH

Coburg, Germany

Location

Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden

Dresden, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätskliniken des Saarlandes

Homburg/Saar, Germany

Location

Universitätsklinikum Jena - Friedrich Schiller Universität

Jena, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Germany

Location

Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

Lüdenscheid, 58515, Germany

Location

Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

Lüdenscheid, Germany

Location

Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, 39120, Germany

Location

Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus

Mönchengladbach, Germany

Location

Klinikum der Universität München - Campus Großhadern

München, Germany

Location

Herz Riesa, Gemeinschaftspraxis

Riesa, Germany

Location

Universitätsklinikum Ulm

Ulm, 89801, Germany

Location

Magyar Honvédség Honvédkorház

Budapest, Hungary

Location

Semmelweis Egyetem AOK

Budapest, Hungary

Location

Medanta - The Medicity

Gūrgaon, India

Location

Fortis Escorts Heart Institute

New Delhi, India

Location

Policlinico Sant' Orsola - Malpighi

Bologna, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale Civile Madonna Della Navicella

Chioggia, Italy

Location

Azienda Ospedaliera Carlo Poma

Mantova, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Location

Chiba University Hospital

Chiba, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Japan

Location

Kyorin University Hospital

Mitaka-Shi, Japan

Location

Nagoya University Hospital

Nagoya, Japan

Location

Sakakibara Heart Institute of Okayama

Okayama, Japan

Location

Saitama Medical Center Jichi Medical University

Shimonoseki-Shi, Japan

Location

National Cerebral and Cardiovascular Center

Suita-Shi, Japan

Location

Fujita Health University Hospital

Toyoake, Japan

Location

University of Fukui Hospital

Tsukuba, Japan

Location

Hospital Angeles Leon

León, Guanajuato, Mexico

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Amphia Ziekenhuis - Locatie Molengracht Breda

Breda, 4818 CK, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Canisius-Wilhelmina ziekenhuis

Nijmegen, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3078 HT, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Location

Isala Klinieken - Locatie Weezenlanden

Zwolle, 8011 JW, Netherlands

Location

Helse Bergen HF - Haukeland Universitetssjukehus

Bergen, Norway

Location

Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu

Kalisz, Poland

Location

Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, Poland

Location

Regional Hospital Szpital Wojewodski

Kielce, Poland

Location

Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

Lublin, Poland

Location

Spital Wojewodzki nr 2

Rzeszów, Poland

Location

Slaskie Centrum Chorob Serca

Zabrze, Poland

Location

Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes

Beja, Portugal

Location

Centro Hospitalar de Coimbra

Coimbra, 3041-801, Portugal

Location

Hospital de Espírito Santo E.P.E.

Evora, 7000, Portugal

Location

The Arrhythmia Group

Coto Laurel, Puerto Rico

Location

Cardiovascular Center

San Juan, Puerto Rico

Location

AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation

Moscow, Russia

Location

EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation

Novosibirsk, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, Russia

Location

King Abdul Aziz University Hospital

Jeddah, Saudi Arabia

Location

King Fahad Armed Forces Hospital

Jeddah, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Location

The College of Medicine & King Khalid University Hospital, King Saud University

Riyadh, Saudi Arabia

Location

Stredoslovensky ustav srdcovych a cievnych chorob a.s

Banská Bystrica, Slovakia

Location

NUSCH, a.s.

Bratislava, 83348, Slovakia

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Nuevo Hospital de Burgos

Burgos, Spain

Location

Hospital Virgen de la Arrixaca

El Palmar, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital Clínico Virgen de la Victoria

Málaga, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes

Vigo, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Karolinska Universitetssjukhuset

Solna, Sweden

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

HFR Fribourg - Hôpital cantonal

Fribourg, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Location

National Taiwan University Hospital Hsin Chu Branch

Hsinchu, 30059, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Golden Jubilee National Hospital - NHS Trust

Glasgow, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Location

University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

Liverpool, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital

London, United Kingdom

Location

Manchester University NHS Foundation Trust - Wythenshawe Hospital

Manchester, United Kingdom

Location

Related Publications (3)

• Wilkoff BL, Filippatos G, Leclercq C, Gold MR, Hersi AS, Kusano K, Mullens W, Felker GM, Kantipudi C, El-Chami MF, Essebag V, Pierre B, Philippon F, Perez-Gil F, Chung ES, Sotomonte J, Tung S, Singh B, Bozorgnia B, Goel S, Ebert HH, Varma N, Quan KJ, Salerno F, Gerritse B, van Wel J, Schaber DE, Fagan DH, Birnie D; AdaptResponse investigators. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial. Lancet. 2023 Sep 30;402(10408):1147-1157. doi: 10.1016/S0140-6736(23)00912-1. Epub 2023 Aug 24.

  PMID: 37634520 DERIVED

• Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.

  PMID: 32790108 DERIVED

• Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895.

  PMID: 28708290 DERIVED

Results Point of Contact

• Title: Janelle van Wel
• Organization: CRM

janelle.van.wel@medtronic.com

+3166 273 886 62

Study Officials

• Bruce Wilkoff, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 31, 2014
• Study Start: August 1, 2014
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Locations

PL (6); DE (17); PT (3); SL (2); ME (1); HU (2); SE (2); FI (2); IN (2); US (90); IT (6); RU (3); AU (4); DK (1); ES (10); PR (2); SA (4); TW (2); FR (17); GB (5); BE (2); KR (6); CH (3); CA (7); NL (8); NO (1); JP (10)