Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

NCT ID: NCT03089281

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 699 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-09-15

Brief Summary

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

Detailed Description

The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SmartDelay™ algorithm

Subjects programmed with AV Delay and pacing chamber determined by SmartDelay

Group Type: OTHER

CRT-D

Intervention Type: 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

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

Group Type: OTHER

CRT-D

Intervention Type: 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.

Interventions

CRT-D

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael R. Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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

Birmingham, Alabama, United States

Heart Center Research LLC

Huntsville, Alabama, United States

University of Arizona Sarver Heart Center

Tucson, Arizona, United States

Cardiology Associates of NE Arkansas

Jonesboro, Arkansas, United States

Glendale Adventist Medical Center

Glendale, California, United States

Salinas Valley Memorial Healthcare System

Salinas, California, United States

Christiana Care Health Services

Newark, Delaware, United States

Baptist Health Research Institute

Jacksonville, Florida, United States

Watson Clinic Center for Research, Inc

Lakeland, Florida, United States

Winter Haven Hospital

Winter Haven, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

The University of Chicago

Chicago, Illinois, United States

St. John's Hospital

Springfield, Illinois, United States

Heart Group at Deaconness Hospital

Newburgh, Indiana, United States

University of Iowa Hospitals

Iowa City, Iowa, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Southcoast Health

Fall River, Massachusetts, United States

Cardiovascular Institute of Michigan

Roseville, Michigan, United States

Trinity Health Michigan d/b/a Michigan Heart

Ypsilanti, Michigan, United States

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, United States

The International Heart Institute on Montana Foundation

Missoula, Montana, United States

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States

The Valley Hospital

Paramus, New Jersey, United States

New York Methodist Hospital

Brooklyn, New York, United States

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

The Ohio Health Research Institute- Grant Medical Center

Columbus, Ohio, United States

Providence Heart Institute

Portland, Oregon, United States

Geisinger Clinic

Danville, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pottstown Medical Specialist, Inc

Pottstown, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

North Central Heart

Sioux Falls, South Dakota, United States

Dallas VA Research Corporation

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Foundation for Advancing Veterans' Health Research

San Antonio, Texas, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, , Canada

Centre hospitalier du pays d'Aix

Aix-en-Provence, , France

CHU Grenoble

Grenoble, , France

CHRU de Lille

Lille, , France

Hopital Saint Philibert

Lille, , France

CHRU Hopital Pontchaillou

Rennes, , France

Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle

Rouen, , France

Centre Hôpital Universitaire Rangueil

Toulouse, , France

Unfalkrankenhaus Marzahn

Berlin, , Germany

University of Berlin, Charite Virchow Standort

Berlin, , Germany

Uni Jena

Jena, , Germany

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, , Germany

Mater Misericordiae University Hospital

Dublin, , Ireland

Ospedale S. Orsola - Malpighi

Bologna, , Italy

Azienda Sanitaria Universtitaria Integrata di Trieste

Trieste, , Italy

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, Japan

Shinshu University Hospital

Nagano, , Japan

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Hospital Infanta Cristina

Badajoz, Extremadura, Spain

Hospital 12 de Octubre Madrid

Madrid, , Spain

Hospital Universitario La Fe

Valencia, , Spain

Cardiocentro Ticino

Lugano, , Switzerland

Royal Sussex County Hospital

Brighton, , United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

Hammersmith Hospital

London, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Nottingham University Hospital

Nottingham, , United Kingdom

Southampton University Hospital

Southampton, , United Kingdom

Countries

United States; Canada; France; Germany; Ireland; Italy; Japan; Netherlands; Spain; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37183700 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C2067

Identifier Type: -

Identifier Source: org_study_id