MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

NCT02006069 | Terminated Results

• 1 other identifier: CR-13-006-ID-HF
• Study Type: interventional
• Target: 5,850
• Locations: 29 countries
• Sites: 203

Brief Summary

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Conditions

Heart Failure

Keywords

CRT, non responders, MultiPoint Pacing (MPP)

Outcome Measures

Primary Outcomes (1)

• Percentage of Non-responder Patients Who Converted to Responders

  The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.

  Non-responder to responder conversion rate between randomization at 6 months and 12 months

Secondary Outcomes (6)

• Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase

  Baseline vs 6 Months

• Clinical Composite Score Evaluation

  Baseline vs 12 Months

• Reverse Left Ventricular (LV) Remodeling

  Baseline vs 12 Months

• NYHA Class Changes

  Baseline vs 12 Months

• 6MWT Changes

  Baseline vs 12 Months

Study Arms (2)

MPP ON

EXPERIMENTAL

MPP ON: feature is enabled

Device: MPP

MPP OFF

NO INTERVENTION

MPP OFF: feature not enabled

Interventions

MPP DEVICE

All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

MPP ON

Eligibility Criteria

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

You may qualify if:

• Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
• Must be willing and able to comply with study requirements
• Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

You may not qualify if:

• Already had a CRT device implanted
• Myocardial Infarction, unstable angina within 40 days prior the enrollment
• Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
• Primary valvular disease
• Atrial Fibrillation:
• Persistent AF at the time of enrollment
• Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
• History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
• Unable to comply with the follow up schedule
• Less than 18 years of age
• Pregnant or are planning to become pregnant during the duration of the investigation
• Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
• Undergone a cardiac transplantation
• Life expectancy \< 12 months

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (206)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Comprehensive Cardiovascular

Bakersfield, California, 93309, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Cardiac Rhythm Specialists, Inc.

Reseda, California, 91335, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Colorado Heart & Vascular, P.C.

Lakewood, Colorado, 80228, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Coliseum Medical Centers

Macon, Georgia, 31217, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

St. Elizabeth Medical Center - South Unit

Edgewood, Kentucky, 41017, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

McLaren Health Care Corporation

Auburn Hills, Michigan, 48326, United States

Location

MidMichigan Medical Center-Midland

Midland, Michigan, 48670, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, 68124, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Cardiology Associates of Fairfield County, PC

Haddon Heights, New Jersey, 08035, United States

Location

Samaritan Heart & Vascular Institute - Cardiology Dept.

Corvallis, Oregon, 97330, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

St. Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9016, United States

Location

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, 76104, United States

Location

Memorial Katy Cardiology Associates

Houston, Texas, 77094, United States

Location

Vivek Mangla, MD

Lufkin, Texas, 75904, United States

Location

EP Heart

The Woodlands, Texas, 77384, United States

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

St. Andrews War Memorial Hospital

Brisbane, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Westmead Hospital

Westmead, Australia

Location

Krankenhaus der Stadt St. Poelten

Sankt Pölten, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Wilhelminenspital

Vienna, Austria

Location

Hopital Erasme

Brussels, Belgium

Location

St. Joseph Gilly

Gilly, Belgium

Location

Foothills Medical Centre

Calgary, Canada

Location

Royal Alexandra Hospital

Edmonton, Canada

Location

QEII Health Sciences

Halifax, Canada

Location

Kingston General Hospital

Kingston, Canada

Location

Hôtel Dieu de CHUM

Montreal, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Canada

Location

McGill University Health Centre General Hospital

Montreal, Canada

Location

Institut de Cardiologie de Quebec

Sainte-Foy, Canada

Location

CHUS Fleurimont

Sherbrooke, J1H 5N4, Canada

Location

HSC, Eastern Health

St. Johns, Canada

Location

Rouge Valley Centenary

Toronto, Canada

Location

St. Paul's Hospital

Vancouver, Canada

Location

Prince of Wales Hospital

Hong Kong, China

Location

Angiografia Clinica de Occidente

Cali, Colombia

Location

Clínica Cardio VID

Medellín, Colombia

Location

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Aalborg Sygehus Syd

Aalborg, North Denmark, DK-9000, Denmark

Location

Skejby University Hospital

Aarhus, Denmark

Location

Keski-Suomi Central Hospital

Jyväskylä, Finland

Location

Turku University Hospital

Turku, Finland

Location

Hôpital Clairval

Marseille, Alpes, 13009, France

Location

CHU Cavale Blanche

Brest, France

Location

CHU Trousseau

Chambray-lès-Tours, France

Location

CHU François Mitterrand Dijon Bourgogne

Dijon, France

Location

CHRU Albert Michallon

Grenoble, France

Location

CHRU Lille

Lille, France

Location

Hopital Saint Philibert

Lomme, France

Location

Hôpital Saint Joseph

Marseille, France

Location

Centre Hospitalier de Belfort-Montbeliard

Montbéliard, France

Location

CHU Montpellier

Montpellier, France

Location

CHU de Nancy - Hopital de Brabois

Nancy, France

Location

CHU Hopital G. & R. Laënnec

Nantes, 44093, France

Location

Nouvelles cliniques Nantaises

Nantes, France

Location

Centre Cardiologique Du Nord

Paris, France

Location

Hopital Pitiè Salpetrière

Paris, France

Location

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Paris, France

Location

CHRU Hôpital de Pontchaillou

Rennes, 35033, France

Location

CHRU Rouen Hospital Charles Nicolle

Rouen, France

Location

CHR de La Reunion - Site du CHFG

Saint-Denis, 97405, France

Location

Centre Hospitalier de Valence

Valence, France

Location

Clinique du Tonkin

Villeurbanne, France

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Hegau-Bodensee-Hochrhein-Kliniken GmbH

Singen, Baden-Wurttemberg, 78224, Germany

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, 61231, Germany

Location

Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem

Göttingen, Lower Saxony, 37073, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Medizinische Einrichtungen der Universität zu Köln

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Evangelisches Krankenhaus Kalk gGmbH

Cologne, North Rhine-Westphalia, 51103, Germany

Location

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, Germany

Location

Schuchtermann-Schillersche Kliniken

Bad Rothenfelde, Germany

Location

Charite Campus Virchow Klinikum

Berlin, Germany

Location

Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Germany

Location

Klinikum Bielefeld

Bielefeld, Germany

Location

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

St. Vinzenz-Hospital

Cologne, Germany

Location

Helios-Klinikum Erfurt GmbH

Erfurt, Germany

Location

Kliniken der Friedrich-Alexander-Universität

Erlangen, Germany

Location

Elisabeth-Krankenhaus Essen GmbH

Essen, Germany

Location

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, Germany

Location

Universitatsklinikum Greifswald

Greifswald, Germany

Location

Klinikum Gütersloh gGmbH

Gütersloh, Germany

Location

Albertinen-Krankenhaus Hamburg

Hamburg, 22457, Germany

Location

Klinikum Ingolstadt

Ingolstadt, Germany

Location

Klinikum St. Georg gGMbH

Leipzig, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Germany

Location

Klinikum Ludenscheid

Lüdenscheid, Germany

Location

St.-Marien-Hospital GmbH

Lünen, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, Germany

Location

Universitatsklinikum Muenster

Münster, Germany

Location

Klinikum Oldenburg

Oldenburg, Germany

Location

Krankenhaus der Barmherzigen Bruder

Trier, Germany

Location

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

The Onassis Cardiac Center

Athens, 17674, Greece

Location

Medanta - The Medicity Hospital

Gurgaon, Haryana, 122 001, India

Location

Fortis Hospital

Bangalore, Karnataka, 560076, India

Location

Care Institute of Medical Sciences

Ahmedabad, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, India

Location

Apollo Hospital

Chennai, India

Location

CARE Banjara

Hyderabad, India

Location

Medanta Medicity Hospital

New Delhi, 110017, India

Location

Escorts Heart Institute and Research Centre

New Delhi, India

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Az.Osp.Universitaria Consorziale Policlinico

Bari, Italy

Location

Azienda Ospedaliera Di Venere

Bari, Italy

Location

Policlinico S.Orsola Malpighi

Bologna, Italy

Location

Az. Osp. Spedali Civili di Brescia

Brescia, Italy

Location

Azienda Ospedaliera S. Anna e S Sebastiano

Caserta, Italy

Location

Presidio Osp. Vito Fazzi

Lecce, Italy

Location

Clinica Mediterranea

Naples, Italy

Location

Ospedale dei Pellegrini

Naples, Italy

Location

Ospedale S. Giovanni Bosco

Naples, Italy

Location

Az Osp.Universitaria Maggiore della Carità

Novara, Italy

Location

Università degli Studi di Padova

Padua, 35128, Italy

Location

Casa di Cura Dott. Pederzoli

Peschiera del Garda, Italy

Location

Az. Osp. Universitaria Pisana-Presidio Santa Chiara

Pisa, Italy

Location

Ospedale di Portogruaro

Portogruaro, Italy

Location

Azienda Ospedaliera "Civile - Maria Paternò Arezzo"

Ragusa, Italy

Location

Ospedale Madre G. Vannini

Roma, 00177, Italy

Location

Policlinico Casilino

Roma, Italy

Location

Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

Rome, Italy

Location

Azienda Ospedaliera S. Anna

San Fermo della Battaglia, 1 22020, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Ospedale Civile Maggiore di Verona Borgo Trento

Verona, Italy

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Mater Dei Hospital

Paola, Malta

Location

Twee Steden Ziekenhuis

Tilburg, North Brabant, 5042 AD, Netherlands

Location

Amsterdam Academic Medical Center (AMC)

Amsterdam, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Isala Ziekenhuis

Zwolle, Netherlands

Location

Szpital Kliniczny Premienienia Panskiego

Poznan, Greater Poland Voivodeship, 61-848, Poland

Location

Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Slaskie Centrum Chorob Serca

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Wojewodzki Specjalistyczny Szpital im. Bieganskiego

Lodz, Poland

Location

Hospital de Braga

Braga, Portugal

Location

Centro Hospitalar do Alto Ave, Unidade de Guimarães

Creixomil, 4835-044, Portugal

Location

Hospital de Santa Cruz

Lisbon, Portugal

Location

Hospital Garcia de Orta, EPE

Lisbon, Portugal

Location

Santa Maria Hospital

Lisbon, Portugal

Location

Centro Hospitalar Vila Nova Gaia

Vila Nova de Gaia, 4434 502, Portugal

Location

Arrhythmia Group

Ponce, Puerto Rico

Location

Heart Rhythm Management

San Juan, Puerto Rico

Location

King Fahad Armed Forces Hospital

Jeddah, 21159, Saudi Arabia

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

National University Hospital

Singapore, Singapore

Location

Samsung Medical Center

Seoul, Gangnam-gu, 135-710, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Seocho-gu, 137-701, South Korea

Location

Sejong General Hospital

Bucheon-si, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University Health System

Seoul, South Korea

Location

Hospital Universitario A Coruña

A Coruña, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Hospital de la Santa Creu y Sant Pau

Barcelona, Spain

Location

Hospital Universitario Virgen de la Nieves

Granada, Spain

Location

Complexo Hospitalario Universitario de Santiago

Madrid, 15706, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

HCU Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Karolinska University Hospital Huddinge

Stockholm, Sweden

Location

Hopital Cantonal Universitaire de Geneva

Geneva, Switzerland

Location

National Taiwan University

Taipei City, Taipei, 10002, Taiwan

Location

Chang Gung Memorial Hospital

Linkou District, 333, Taiwan

Location

Wansbeck General Hospital

Ashington, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

The Royal Sussex Country Hospital

Brighton, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

St. Thomas Hospital

London, United Kingdom

Location

Manchester Heart Center, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

The Great Western Hospital

Swindon, United Kingdom

Location

Related Publications (2)

• Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.

  PMID: 30859220 DERIVED

• Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Cohorn C, Thibault B; MORE-CRT MPP Investigators. Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II). Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.

  PMID: 30616009 DERIVED

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kwangdeok Lee PhD
• Organization: Abbott

kwangdeok.lee@abbott.com

+19725269673

Study Officials

• Christophe Leclercq

  Centre Cardio-Pneumologique, CHU Pontchaillou

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6); CA (12); AU (5); DK (3); LE (1); MY (1); PL (4); FI (2); IL (3); SA (2); ES (14); BE (2); PT (6); SE (1); FR (21); DE (33); IN (8); CN (1); GB (10); GR (1); US (32); PR (2); IT (21); CH (1); CO (2); SG (1); NL (5); MA (1); TW (2)