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

CVRx

Status

Terminated

Conditions

Heart Failure

Treatments

Device: Barostim™ System

Study type

Observational

Funder types

Industry

Identifiers

NCT05860348

360064-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Volunteers

No Healthy Volunteers

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.