Trial record 5 of 5177 for:
hypertension
Device Based Therapy in Hypertension Trial (DEBuT-HT)
This study has been completed.
Sponsor:
CVRx, Inc.
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00710190
First received: July 1, 2008
Last updated: October 28, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.
| Condition | Intervention |
|---|---|
|
Hypertension |
Device: Rheos Baroreflex Hypertension Therapy System |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Baroreflex Hypertension Therapy in Refractory Hypertension |
Resource links provided by NLM:
Further study details as provided by CVRx, Inc.:
Primary Outcome Measures:
- The purpose of this clinical investigation is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension. [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2003 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: Rheos Baroreflex Hypertension Therapy System
This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.
The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension TherapyT 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710190
Locations
| Czech Republic | |
| University Hospital Hradec Kralove | |
| Hradec Kralove, Czech Republic | |
| Germany | |
| University Hospital Bad Oeynhausen | |
| Bad Oeynhausen, Germany | |
| Charité Campus Buch | |
| Berlin, Germany | |
| Uniklinik Essen | |
| Essen, Germany | |
| University Hospital Hannover | |
| Hannover, Germany | |
| Latvia | |
| Latvian Centre of Cardiology | |
| Riga, Latvia | |
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland | |
| Switzerland | |
| Inselspital Bern | |
| Bern, Switzerland | |
Sponsors and Collaborators
CVRx, Inc.
Investigators
| Study Director: | Thomas Baal, PhD | CVRx, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | CVRx, Inc. |
| ClinicalTrials.gov Identifier: | NCT00710190 History of Changes |
| Other Study ID Numbers: | 360004-001 |
| Study First Received: | July 1, 2008 |
| Last Updated: | October 28, 2011 |
| Health Authority: | Germany: Ethics Commission Netherlands: Independent Ethics Committee |
Keywords provided by CVRx, Inc.:
|
Drug Resistant Hypertension Refractory Hypertension High Blood Pressure Baroreflex Hypertension Therapy |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013