Rheos Feasibility Trial

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Other: Standard of care medical management; Device: Implantation of the Rheos System

• Registration Number: NCT01077180
• Lead Sponsor: CVRx, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-12
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Completion: 2010-10
• Status Verified: 2016-10
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medical Management	Standard of care medical management	-
Rheos Device	Implantation of the Rheos System	-

Primary Outcome Measures

Name	Time	Method
Rheos Feasibility Study	13 months	To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant).; To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant.