Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Medtronic Vascular4 sites in 2 countries50 target enrollmentSeptember 2012

ConditionsUncontrolled Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Uncontrolled Hypertension
Sponsor: Medtronic Vascular
Enrollment: 50
Locations: 4
Primary Endpoint: Acute safety as measured by procedural complications
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

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.