Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension
Phase 3
Completed
- Conditions
- Blood Pressure, HighHypertensionBlood Pressure, ResistantBlood Pressure, Uncontrolled
- Interventions
- Device: ROX COUPLER
- Registration Number
- NCT01885390
- Lead Sponsor
- ROX Medical, Inc.
- Brief Summary
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
- Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.
Exclusion Criteria
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: Group A ROX COUPLER ROX Coupler + continuing standard antihypertensive medications
- Primary Outcome Measures
Name Time Method Change in ambulatory daytime mean systolic blood pressure Baseline, 6 months Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.
- Secondary Outcome Measures
Name Time Method Change in ambulatory daytime mean diastolic blood pressure Baseline, 6 months Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.
Trial Locations
- Locations (4)
Queen Mary University of London
🇬🇧London, United Kingdom
ZNA Cardio Middelheim
🇧🇪Antwerp, Belgium
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
East Sussex Healthcare NHS Trust
🇬🇧Eastbourne, United Kingdom