CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02064764
NCT02064764N/ACompleted

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

Medtronic Vascular·interventional·Posted Feb 17, 2014·Updated Feb 23, 2024

In Brief

A clinical study evaluating Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Arctic Front Advance™ Cardiac Cryoablation System for Atrial Fibrillation and Hypertension. Completed, enrolled 102 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2014
Enrollment StartFeb 1, 2015
Primary CompletionApr 19, 2021
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 12.4 years ago

Interventions

Symplicity Spyral™ Multi-Electrode Renal Denervation Catheterdevice

Arctic Front Advance™ Cardiac Cryoablation Systemdevice