NCT01699529CompletedNot Applicable
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Medtronic Vascular7 sites in 2 countries50 target enrollmentStarted: September 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Acute safety as measured by procedural complications
Study Overview
Brief Summary
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individual is ≥ 18 and ≤ 80 years old.
- •Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
- •Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.
Exclusion Criteria
- •Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- •Individual has type 1 diabetes mellitus
- •Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- •Individual has primary pulmonary hypertension.
- •Individual is pregnant, nursing or planning to be pregnant.
Outcomes
Primary Outcomes
Acute safety as measured by procedural complications
Time Frame: 1 month
Secondary Outcomes
- Change in Office Systolic Blood Pressure(Baseline to 6 months)
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Not Applicable
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant HypertensionHypertensionNCT01499810Tomsk National Research Medical Center of the Russian Academy of Sciences53
Completed
Not Applicable
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension PatientsHypertensionNCT01438229Abbott Medical Devices47
Recruiting
Not Applicable
DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive MedicationsVascular DiseasesCardiovascular DiseasesHypertensionNCT04535050Kalos Medical100
Completed
Not Applicable
Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of HypertensionMetabolic SyndromeHypertensionNCT04740723Metavention30
Withdrawn
Not Applicable
Renal Denervation in Patients With Chronic Heart FailureCardio-Renal SyndromeChronic Heart FailureNCT02085668University Hospital, Saarland