A Prospective, Multi-center, Non-randomized, Controlled Trial in India to Evaluate Efficacy and Safety of Renal Denervation in the Treatment of Uncontrolled Hypertension

Medtronic Vascular1 site in 1 country14 target enrollmentOctober 2013

ConditionsAdults With Uncontrolled Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adults With Uncontrolled Hypertension
Sponsor: Medtronic Vascular
Enrollment: 14
Locations: 1
Primary Endpoint: Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45 subjects. The study will be conducted at up to 8 actively enrolling investigational sites. The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months post-procedure.

Detailed Description

Estimated enrollment Start: May 2013 (estimated 90 day duration) Estimated last follow-up: September 2013 Follow-Up Duration: Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

December 2014

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 at time of treatment.
•Individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
•Individual has an office systolic blood pressure of 160 mm Hg based on an average of 3 blood pressure readings measured at screening visits
•Individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria

•Individual has renal artery anatomy that is ineligible for treatment including:
•Main renal arteries with less than 4 mm diameter or with less than 20 mm treatable length
•Multiple renal arteries where the main renal artery is estimated to supply less than 75 percent of the kidney.
•Renal artery stenosis more than 50 percent or renal artery aneurysm in either renal artery.
•A history of prior renal artery intervention including balloon angioplasty or stenting.
•Individual has an estimated glomerular filtration rate of less than 45mL per min per 1.73m2, using the MDRD calculation.
•Individual has had more than 1 in-patient hospitalization for a hypertensive crisis within the past year.
•Individual has type 1 diabetes mellitus.
•Individual has had 1 or more episodes of symptomatic orthostatic hypotension within the past year or during the screening process.
•Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.