NCT01632943

Single-arm Study of Symplicity™ Renal Denervation System in Patients With Uncontrolled HyperTensioN in India

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adults With Uncontrolled Hypertension

Interventions

Type	Name	Description
DEVICE	Symplicity renal denervation system	Previous research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure. A less invasive approach to disrupting these nerves is to apply a brief high temperature near the nerves (renal denervation). This can now be done with an experimental medical device called the Symplicity renal denervation system. The System includes a catheter that is inserted into your blood vessels and an RF-generator.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2012-07-04
• Last updated: 2017-02-07

Locations

1 site across 1 country: India