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Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence

Heart Failure Clinical Trial

Official title:
Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System

Clinical Trial Summary

The purpose of this study is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that are symptomatic despite having received CRT.

Clinical Trial Description

This is a non-randomized, prospective, multicenter complementary-study of the REBALANCE Registry. Patients who have been implanted with a CRT device at least 6-months prior to enrollment are eligible for this complementary-study. Up to 150 subjects will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05860348
Study type Observational [Patient Registry]
Source CVRx, Inc.
Contact Elizabeth Galle
Phone 763-416-2876
Email lgalle@cvrx.com
Status Recruiting
Phase
Start date November 2023
Completion date May 2028
View Details
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