Heart Failure
Conditions
Keywords
Heart Failure, CRT, Cardiac Recynchronization Therapy, left bundle branch block, atrio-ventricular conduction
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.
Interventions
DEVICEAdaptiv CRT
Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit
Sponsors
Stern Cardiovascular Foundation, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ejection fraction | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular end systolic volume | 12 months | As determined by echocardiographic evidence |
| Atrial fibrillation burden | 12 Months | Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review |
| Percentage of RV synchronized LV pacing | 12 months | Percentage determined by device interrogation and compared to clinical outcomes |
| Time to first appropriate therapy for VT and/or VF | 12 months | Time determined by device interrogation from sensing to response |
| Heart failure hospitalizations | 12 months | Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects |
Countries
United States
Outcome results
None listed