Heart Failure Clinical Trial
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Summary
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.
Eligibility Criteria
Inclusion Criteria:
Normal AV conduction (SAV<220 ms or PAV<270 MS)
Left Bundle Branch Block (defined as > or = to 140 ms (male) or > or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
Sinus Rhythm at the time of enrollment
Exclusion Criteria:
Moderate to severe Aortic Stenosis
Moderate to severe Mitral Regurgitation
Patient age <18 years old
AF burden >15%
Severe pulmonary disease requiring supplemental oxygen use
ESRD
System Modification at RRT Generator Changeout
AdaptivCRT prior to enrollment
Expected patient longevity < 1 year
Persistant or chronic atrial fibriliation
Women who are pregnant or who plan to become pregnant during the clinical trial
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There is 1 Location for this study
Germantown Tennessee, 38138, United States
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