Device Based Therapy in Hypertension Trial | NCT00710190

Studies
Device Based Therapy in Hypertension Trial

NCT00710190

Sponsor

CVRx, Inc.

Status

Completed

Last Update Posted

Oct 21, 2016Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Rheos Baroreflex Hypertension Therapy System

Countries

Czechia
Germany
Latvia
Netherlands
Poland
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 3, 2008

First Posted Date

Jul 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2016

Last Update Posted Date

Oct 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Label	Type	Description	Intervention Names
Rheos Implant	Experimental		Device: Rheos Baroreflex Hypertension Therapy System

Name	Type	Description	Arm Group Labels	Other Names
Rheos Baroreflex Hypertension Therapy System	Device	This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.	Rheos Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Hradec Kralove		Hradec Králové			Czechia
University Hospital Bad Oeynhausen

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases