NCT01438229

Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

Ablation-induced Renal Sympathetic Denervation Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Detailed description

Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension. Safety Marker * All adverse events Efficacy Marker * Office blood pressure

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)	Catheter-based RF ablation in renal artery

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2014-07-01
• First posted: 2011-09-22
• Last updated: 2019-02-05
• Results posted: 2015-05-21

Locations

4 sites across 2 countries: Australia, Greece