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

Stern Cardiovascular Foundation, Inc.

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Adaptiv CRT

Study type: Interventional

Funder types: Industry

Identifiers

NCT03305393

IMPROVE RESPONSE

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Adaptiv CRT

Other group

Description:

Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit

Treatment:

Device: Adaptiv CRT