Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Stern Cardiovascular Foundation, Inc.
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Ejection fraction
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Ejection fraction
Time Frame: 12 Months
Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
NYHA functional class
Time Frame: 12 months
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Secondary Outcomes
- Left ventricular end systolic volume(12 months)
- Atrial fibrillation burden(12 Months)
- Heart failure hospitalizations(12 months)
- Time to first appropriate therapy for VT and/or VF(12 months)
- Percentage of RV synchronized LV pacing(12 months)