Rheos Feasibility Trial

CVRx

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Other: Standard of care medical management; Device: Implantation of the Rheos System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01077180

360005-001

Details and patient eligibility

About

The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.

Enrollment: 16 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be at least 21 years of age.
2. Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
3. Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
4. Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
5. Have signed a CVRx approved informed consent for participation in this study.

Exclusion criteria

1. Have been diagnosed with:

   • Baroreflex failure
   • Cardiac bradyarrhythmias
   • Chronic atrial fibrillation

2. Had a heart transplant

3. Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.

4. Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.

5. Have prior surgery or radiation in either carotid sinus region.

6. Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.

7. Are pregnant or contemplating pregnancy during the 13-month follow-up period.

8. Currently undergoing dialysis.

9. Have hypertension secondary to a treatable cause.

10. Have clinically significant cardiac valvular disease.

11. Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.

12. Are unlikely to survive the protocol follow-up period.

13. Are enrolled in another concurrent clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Rheos Device

Experimental group

Treatment:

Device: Implantation of the Rheos System

Medical Management

Active Comparator group

Treatment:

Other: Standard of care medical management