Status:
COMPLETED
AdaptResponse Clinical Trial
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure With Left Bundle Branch Block
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
3797 Patients enrolled
Trial Details
Trial ID
NCT02205359
Start Date
August 1 2014
End Date
November 2 2022
Last Update
November 29 2023
Active Locations (220)
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1
CardioVascular Associates of Mesa
Mesa, Arizona, United States, 85206
2
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, United States, 85018-3956
3
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205-6202
4
Scripps Green Hospital Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037-1027