AdaptResponse Clinical Study (AdaptResponse Clinical Study)

Completed

• Conditions: Heart Failure

• Registration Number: jRCTs052180128

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-10
• Study First Submitted: 2019-03-18
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1 Subject is willing to sign and date the study Patient Informed Consent (PIC) Form. 2 Subject is indicated for a CRT device according to local guidelines. 3 Sinus Rhythm at time of enrollment. 4 Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Criteria16 for complete LBBB must include: -Intrinsic QRS duration >=140 ms (men) or >=130 ms (women), -QS or rS in leads V1 and V2 -Mid-QRS notching or slurring in >=2 of leads V1, V2, V5, V6, I, and aVL. 5 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). 6 Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment). 7 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

1 Subject is less than 18 years of age (or has not reached minimum age per local law). 2 Subject is not expected to remain available for at least 2 years of follow-up visits. 3 Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted. 4 Subject is, or previously has been, receiving cardiac resynchronization therapy. 5 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. 6 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. 7 Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. 8 Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded). 9 Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. 10 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). 11 Subject meets any exclusion criteria required by local law.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
combined endpoint of all-cause mortality and intervention for heart failure decompensation		To test the hypothesis that AdaptivCRT reduces the incidence of the combined endpoint of **all-cause mortality** and **intervention for heart failure decompensation**, compared to standard CRT therapy, in patients with a CRT indication, LBBB and normal AV conduction.