Overview

This trial is active, not recruiting.

Condition uncontrolled hypertension
Treatment medtronic multi-electrode radiofrequency (rf) renal denervation system
Sponsor Medtronic Vascular
Start date September 2012
End date March 2014
Trial size 50 participants
Trial identifier NCT01699529, 10058715DOC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
medtronic multi-electrode radiofrequency (rf) renal denervation system
The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.

Primary Outcomes

Measure
Acute safety as measured by procedural complications
time frame: 1 month

Secondary Outcomes

Measure
Change in Office Systolic Blood Pressure
time frame: Baseline to 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Principal investigator Robert Whitbourn, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.