Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Adaptiv CRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adaptiv CRT<br>Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit | Device: Adaptiv CRT<br>* Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation burden | Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review | 12 Months | 
| Heart failure hospitalizations | Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects | 12 months | 
| Left ventricular end systolic volume | As determined by echocardiographic evidence | 12 months | 
| Time to first appropriate therapy for VT and/or VF | Time determined by device interrogation from sensing to response | 12 months | 
| Percentage of RV synchronized LV pacing | Percentage determined by device interrogation and compared to clinical outcomes | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrio-ventricular conduction, Heart Failure, CRT, Cardiac Recynchronization Therapy, left bundle branch block