Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

NCT03089281 | Completed Results FDA Device

• 1 other identifier: C2067
• Study Type: interventional
• Target: 699
• Locations: 11 countries
• Sites: 72

Brief Summary

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• CRT Response

  Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) \< -15% at 6 months compared to pre-implant baseline.

  Pre-Implant baseline to 6 months

Secondary Outcomes (6)

• Change in Left Ventricular End Systolic Volume (Absolute Change)

  Implant to 6 Months

• Change in Left Ventricular End Systolic Volume (Relative Change)

  Implant to 6 Months

• Change in Left Ventricular Ejection Fraction (Absolute Change)

  Implant to 6 Months

• Change in Left Ventricular Ejection Fraction (Relative Change)

  Implant to 6 Months

• Clinical Composite Score (CCS)

  Implant to 6 Months

Other Outcomes (6)

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Social Limitation Score

  Implant to 6 Months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score

  Implant to 6 Months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Self-Efficacy Score

  Implant to 6 Months

Study Arms (2)

SmartDelay™ algorithm

OTHER

Subjects programmed with AV Delay and pacing chamber determined by SmartDelay

Device: CRT-D

Fixed AV Delay with BiV pacing

OTHER

Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing

Device: CRT-D

Interventions

CRT-D DEVICE

Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.

Fixed AV Delay with BiV pacing; SmartDelay™ algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
• In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
• Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
• Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
• Subject is willing and capable of providing informed consent
• Subject is willing and capable of complying with visits and procedures as defined by this protocol

You may not qualify if:

• Subjects with documented permanent complete AV block
• Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
• Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
• Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
• Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
• Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
• Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
• Women of childbearing potential who are or plan to become pregnant during the course of the trial
• Subjects currently requiring dialysis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (72)

Affinity Hospital, LLC d/b/a Granview Medical Center

Birmingham, Alabama, 35243, United States

Location

Heart Center Research LLC

Huntsville, Alabama, 35801, United States

Location

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724, United States

Location

Cardiology Associates of NE Arkansas

Jonesboro, Arkansas, 72401, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Salinas Valley Memorial Healthcare System

Salinas, California, 93901, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Watson Clinic Center for Research, Inc

Lakeland, Florida, 33805, United States

Location

Winter Haven Hospital

Winter Haven, Florida, 33881, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Heart Group at Deaconness Hospital

Newburgh, Indiana, 47630, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Southcoast Health

Fall River, Massachusetts, 02720, United States

Location

Cardiovascular Institute of Michigan

Roseville, Michigan, 48066, United States

Location

Trinity Health Michigan d/b/a Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

The International Heart Institute on Montana Foundation

Missoula, Montana, 59802, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

The Ohio Health Research Institute- Grant Medical Center

Columbus, Ohio, 43215, United States

Location

Providence Heart Institute

Portland, Oregon, 97225, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pottstown Medical Specialist, Inc

Pottstown, Pennsylvania, 19464, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Dallas VA Research Corporation

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Foundation for Advancing Veterans' Health Research

San Antonio, Texas, 78229, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Canada

Location

Centre hospitalier du pays d'Aix

Aix-en-Provence, 13616, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHRU de Lille

Lille, 59037, France

Location

Hopital Saint Philibert

Lille, 59160, France

Location

CHRU Hopital Pontchaillou

Rennes, 35000, France

Location

Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle

Rouen, 76031, France

Location

Centre Hôpital Universitaire Rangueil

Toulouse, 31059, France

Location

Unfalkrankenhaus Marzahn

Berlin, 12683, Germany

Location

University of Berlin, Charite Virchow Standort

Berlin, 13353, Germany

Location

Uni Jena

Jena, 07747, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, 84036, Germany

Location

Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, 39120, Germany

Location

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

Location

Ospedale S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Azienda Sanitaria Universtitaria Integrata di Trieste

Trieste, 34129, Italy

Location

Hirosaki University Hospital

Hirosaki-shi, Aomori, 036-8562, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, 734-8530, Japan

Location

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

Shinshu University Hospital

Nagano, Japan

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Hospital Infanta Cristina

Badajoz, Extremadura, 06080, Spain

Location

Hospital 12 de Octubre Madrid

Madrid, 28041, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Cardiocentro Ticino

Lugano, CH-6900, Switzerland

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

University Hospital of Wales

Cardiff, CF144XW, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Southampton University Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Gold MR, Ellenbogen KA, Leclercq C, Lowy J, Rials SJ, Shoda M, Tomassoni G, Issa Z, Sarrazin JF, Jennings JM, Nair DG, Wold N, Yong P, Harbin MM, Stein KM, Auricchio A. Effects of Atrioventricular Optimization on Left Ventricular Reverse Remodeling With Cardiac Resynchronization Therapy: Results of the SMART-CRT Trial. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011714. doi: 10.1161/CIRCEP.122.011714. Epub 2023 May 15.

  PMID: 37183700 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Boston Scientific

Sara.Veraghtert@bsci.com

1-800-227-3422

Study Officials

• Michael R. Gold, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 19, 2017
• First Posted: March 24, 2017
• Study Start: August 1, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-04

Locations

JP (4); NL (1); CH (1); CA (1); IT (2); IE (1); US (41); FR (7); DE (5); ES (3); GB (6)