BAROSTIM THERAPY™ In Resistant Hypertension

CVRx

Status: Enrolling

Conditions: Hypertension

Treatments: Device: BAROSTIM NEO™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT02880631

360051-001

Details and patient eligibility

About

The purpose of this registry (NCT02880631) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension.

Full description

Summary:

The CVRx BAROSTIM THERAPY in Resistant Hypertension Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry.

Eligibility:

Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate.

Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These include:

• Indications

  • Systolic blood pressure greater than or equal to 140 mmHg, and
  • Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications

• Contraindications

  • Bilateral carotid bifurcations located above the level of the mandible
  • Baroreflex failure or autonomic neuropathy
  • Uncontrolled, symptomatic cardiac bradyarrhythmias
  • Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
  • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has signed an EC approved informed consent form
• Has been implanted with the BAROSTIM NEO system in the past 30 days
• Systolic blood pressure greater than or equal to 140 mmHg, and
• Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications

Exclusion criteria

• Bilateral carotid bifurcations located above the level of the mandible
• Baroreflex failure or autonomic neuropathy
• Uncontrolled, symptomatic cardiac bradyarrhythmias
• Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
• Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation