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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2016 |
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Main ID: |
NCT00710190 |
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Date of registration:
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01/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Device Based Therapy in Hypertension Trial
DEBuT-HT |
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Scientific title:
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A Study of Baroreflex Hypertension Therapy in Refractory Hypertension |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00710190 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Czech Republic
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Germany
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Latvia
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Netherlands
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Poland
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Switzerland
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Contacts
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Name:
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Thomas Baal, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CVRx, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Device: Rheos Baroreflex Hypertension Therapy System
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Primary Outcome(s)
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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: 4 months post implant]
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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.
[Time Frame: 4 months post implant]
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Secondary ID(s)
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360004-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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