Rheos Feasibility Trial

NCT ID: NCT01077180

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2010-10-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rheos Device

Group Type: EXPERIMENTAL

Implantation of the Rheos System

Intervention Type: DEVICE

Open label

Medical Management

Group Type: ACTIVE_COMPARATOR

Standard of care medical management

Intervention Type: OTHER

Patients will continue with medical therapy for standard of care of their hypertension.

Interventions

Implantation of the Rheos System

Open label

Intervention Type: DEVICE

Standard of care medical management

Patients will continue with medical therapy for standard of care of their hypertension.

Intervention Type: OTHER

Eligibility Criteria

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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• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CVRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

360005-001

Identifier Type: -

Identifier Source: org_study_id