Rheos Feasibility Trial

Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Implantation of the Rheos System; Other: Standard of care medical management

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medical Management	Other: Standard of care medical management; Patients will continue with medical therapy for standard of care of their hypertension.
Experimental: Rheos Device	Device: Implantation of the Rheos System; Open label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rheos Feasibility Study	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.	13 months

Collaborators and Investigators

• Sponsor: CVRx, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 360005-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes