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

NCT03305393 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-09-19

No results posted yet for this study

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

Interventions

DEVICE

Adaptiv CRT

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

Sponsors & Collaborators

  • Stern Cardiovascular Foundation, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-11
Primary Completion
2018-07-03
Completion
2018-07-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305393 on ClinicalTrials.gov