Device Based Therapy in Hypertension Trial

Hypertension Clinical Trial

— DEBuT-HT  

Official title:

A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710190
• Other study ID #: 360004-001
• Status: Completed
• Phase: N/A
• First received: July 1, 2008
• Last updated: October 19, 2016
• Start date: July 2003
• Est. completion date: October 2011

Study information

• Verified date: October 2016
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionNetherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Rheos Baroreflex Hypertension Therapy System
This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.

Locations

Country	Name	City	State
Czech Republic	University Hospital Hradec Kralove	Hradec Kralove
Germany	University Hospital Bad Oeynhausen	Bad Oeynhausen
Germany	Charité Campus Buch	Berlin
Germany	Uniklinik Essen	Essen
Germany	University Hospital Hannover	Hannover
Latvia	Latvian Centre of Cardiology	Riga
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Poland	Medical University of Gdansk	Gdansk
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

Czech Republic,  Germany,  Latvia,  Netherlands,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No

External Links

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