Device Based Therapy in Hypertension Trial

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Rheos Baroreflex Hypertension Therapy System

• Registration Number: NCT00710190
• Lead Sponsor: CVRx, Inc.

Brief Summary

The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.

Detailed Description

The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. An assessment of safety and efficacy will be made at the 4-month follow-up. Enrolled patients will be followed annually thereafter.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Be at least 21 years of age.
• Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
• Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months 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 as compliant to taking full doses of medications.
• Have signed an approved informed consent form for participation in this study.

Exclusion Criteria

• Have been diagnosed with:

  • Baroreflex failure or significant orthostatic hypotension
  • Cardiac brady arrhythmias or chronic atrial fibrillation

• Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.

• 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 4-month follow-up period.

• Are on dialysis

• Have hypertension secondary to a treatable cause

• Have clinically significant cardiac valvular disease

• Are unable to comply with protocol requirements.

• Are unlikely to survive the protocol follow-up period

• Are enrolled in another concurrent clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rheos Implant	Rheos Baroreflex Hypertension Therapy System	-

Primary Outcome Measures

Name	Time	Method
Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate.	4 months post implant
Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy.	4 months post implant

Trial Locations

Locations (9)

University Hospital Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

University Hospital Hannover; 🇩🇪 Hannover, Germany

Uniklinik Essen; 🇩🇪 Essen, Germany

Charité Campus Buch; 🇩🇪 Berlin, Germany

Latvian Centre of Cardiology; 🇱🇻 Riga, Latvia

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Medical University of Gdansk; 🇵🇱 Gdansk, Poland

Inselspital Bern; 🇨🇭 Bern, Switzerland

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czech Republic