NCT02064764

Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.

Conditions

• Atrial Fibrillation
• Hypertension

Interventions

Type	Name	Description
DEVICE	Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
DEVICE	Arctic Front Advance™ Cardiac Cryoablation System

Timeline

• Start date: 2015-02-01
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2014-02-17
• Last updated: 2024-02-23
• Results posted: 2024-02-23

Locations

10 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study