Rheos Feasibility Trial

NCT01077180 | Completed Phase 2 DMC FDA Device

• 1 other identifier: 360005-001
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rheos Device

EXPERIMENTAL

Device: Implantation of the Rheos System

Medical Management

ACTIVE COMPARATOR

Other: Standard of care medical management

Interventions

Implantation of the Rheos System DEVICE

Open label

Rheos Device

Standard of care medical management OTHER

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

Medical Management

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 21 years of age.
• Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
• 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.
• Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
• Have signed a CVRx approved informed consent for participation in this study.

You may not qualify if:

• Have been diagnosed with:
• Baroreflex failure
• Cardiac bradyarrhythmias
• Chronic atrial fibrillation
• Had a heart transplant
• 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.
• Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
• Have prior surgery or radiation in either carotid sinus region.
• Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
• Are pregnant or contemplating pregnancy during the 13-month follow-up period.
• Currently undergoing dialysis.
• Have hypertension secondary to a treatable cause.
• Have clinically significant cardiac valvular disease.
• Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
• Are unlikely to survive the protocol follow-up period.

Sponsors & Collaborators

• CVRx, Inc.: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: October 1, 2010
• Last Updated: July 2, 2019

Record last verified: 2016-10