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

CVRx, Inc.5 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Interventions

Barostim™ SystemDEVICE

Implantation of the Barostim™ System

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients can be included if they were implanted with a cardiac resynchronization therapy (CRT) device at least six months (180 days) prior to informed consent and are planned for a de novo Barostim System implantation. Patients must sign an informed consent form before implantation with the Barostim System in order to participate in this study. Exclusion Criteria: * Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.

Locations (3)

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

Florida Heart Rhythm Specialists

Fort Lauderdale, Florida, United States

Advanced Cardiology

Hackettstown, New Jersey, United States

Outcomes

Primary Outcomes

Change in Six Minute Hall Walk

Changes in Six Minute Hall Walk distance through 36 months post-implant

Time frame: 36 months post-implant

Secondary Outcomes

Change in Minnesota Living with Heart Failure Quality of Life

Changes in Minnesota Living with Heart Failure Quality of Life through 6 months post-implant

Time frame: 6 months post-implant

Change NYHA Class

Changes in NYHA Classification through 6 months post-implant

Time frame: 6 months post-implant

Data from ClinicalTrials.gov

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