AdaptResponse Clinical Trial

Medtronic Cardiac Rhythm and Heart Failure220 sites in 1 country3,797 target enrollmentAugust 2014

ConditionsHeart Failure With Left Bundle Branch Block

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure With Left Bundle Branch Block
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 3797
Locations: 220
Primary Endpoint: Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

November 2, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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).

Outcomes

Primary Outcomes

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

Time Frame: 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)

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

Secondary Outcomes

All-cause Mortality(from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years))
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)
Change in Quality of Life Measured by the EQ-5D(from baseline to 24M follow up)
All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years(from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years))
Clinical Composite Score(CCS at 6 month post randomization)
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))