BAROSTIM NEO System in the Treatment of Heart Failure

CVRx

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: Medical Management; Device: BAROSTIM NEO System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471860

360029

Details and patient eligibility

About

The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

Full description

The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.

During long-term follow-up, all participants are required to have at least one annual visit.

Parameters assessed during long-term follow-up visits:

• Physical Assessment
• Subject Medications
• Serious adverse events

Enrollment: 94 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Actively participating in the Neo Randomized Heart Failure Study.
• Have signed a revised approved informed consent form for continued participation in this study.

Exclusion criteria

• Treating physician decision that the subject should not continue with therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

Device and Medical Management

Experimental group

Description:

Medical Management, to be determined by the participant's physician, described as: * Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling. * Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications. Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.

Treatment:

Drug: Medical Management

Device: BAROSTIM NEO System