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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Ejection fraction
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
Time frame: 12 Months
NYHA functional class
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Time frame: 12 months
Atrial fibrillation burden
Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review
Time frame: 12 Months
Heart failure hospitalizations
Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects
Time frame: 12 months
Left ventricular end systolic volume
As determined by echocardiographic evidence
Time frame: 12 months
Time to first appropriate therapy for VT and/or VF
Time determined by device interrogation from sensing to response
Time frame: 12 months
Percentage of RV synchronized LV pacing
Percentage determined by device interrogation and compared to clinical outcomes
Time frame: 12 months
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