BAROSTIM NEO Hypertension Pivotal Trial

CVRx

Status: Suspended

Conditions: Uncontrolled Hypertension

Treatments: Device: BAROSTIM NEO System and Medical Management

Study type: Interventional

Funder types: Industry

Identifiers

NCT01679132

360039

Details and patient eligibility

About

The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

Full description

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

• Office Cuff Blood Pressure
• Physical Assessment
• Subject Medications
• Serious adverse events

Enrollment: 10 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
• 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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10 participants in 1 patient group

BAROSTIM NEO System

Experimental group

Description:

Subjects implanted with the BAROSTIM NEO System.

Treatment:

Device: BAROSTIM NEO System and Medical Management