CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
Renal Artery Ablation +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/NCT01907828
NCT01907828N/ACompleted
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A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

Abbott Medical Devices·interventional·Posted Jul 25, 2013·Updated May 22, 2020

In Brief

A clinical study evaluating Renal Artery Ablation and Cardiac Ablation for Persistent Atrial Fibrillation and 2 related conditions. Completed, enrolled 61 participants across 2 sites.

Detailed Summary

The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being treated for Atrial Fibrillation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 25, 2013
Enrollment StartApr 15, 2014
Primary CompletionOct 15, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.9 years ago

Interventions

Renal Artery Ablationdevice

Renal artery denervation using the EnligHTN™ Renal Denervation System

Cardiac Ablationdevice

Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer