AdaptResponse Clinical Trial

Medtronic

Status: Completed

Conditions: Heart Failure With Left Bundle Branch Block

Treatments: Device: aCRT OFF; Device: aCRT ON

Study type: Interventional

Funder types: Industry

Identifiers

NCT02205359

AdaptResponse

Details and patient eligibility

About

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).

Enrollment: 3,797 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).
• Subject meets any exclusion criteria required by local law.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,797 participants in 2 patient groups

aCRT ON

Experimental group

Description:

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

Treatment:

Device: aCRT ON

aCRT OFF

Active Comparator group

Description:

Standard CRT

Treatment:

Device: aCRT OFF