Device Based Therapy in Hypertension Trial (DEBuT-HT)

This study has been completed.
Sponsor:
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

July 1, 2008
October 28, 2011
July 2003
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00710190 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Device Based Therapy in Hypertension Trial
A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: Rheos Baroreflex Hypertension Therapy System
This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Germany,   Switzerland,   Latvia,   Poland,   Czech Republic
 
NCT00710190
360004-001
No
CVRx, Inc.
CVRx, Inc.
Not Provided
Study Director: Thomas Baal, PhD CVRx, Inc.
CVRx, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP