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

NCT ID: NCT03305393

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-11
• Study Completion Date: 2018-07-03

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptiv CRT

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

Group Type: OTHER

Adaptiv CRT

Intervention Type: DEVICE

Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit

Interventions

Adaptiv CRT

Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stern Cardiovascular Foundation, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Countries

United States

Other Identifiers

IMPROVE RESPONSE

Identifier Type: -

Identifier Source: org_study_id