NCT01972139

Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

Detailed description

After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.

Conditions

• Hypertension
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Renal Denervation using the Symplicity Renal Denervation System	Subjects randomized to the renal denervation group underwent angiography and renal denervation.
OTHER	Sham Renal Denervation	Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
DEVICE	Renal Angiography	Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-07-01
• Completion: 2017-01-01
• First posted: 2013-10-30
• Last updated: 2017-04-26

Locations

3 sites across 1 country: United States