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A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

NCT01907828 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-05-22

Study results available
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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

Conditions

  • Persistent Atrial Fibrillation
  • Paroxysmal Atrial Fibrillation
  • Hypertension

Interventions

DEVICE

Renal Artery Ablation

Renal artery denervation using the EnligHTN™ Renal Denervation System

DEVICE

Cardiac Ablation

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Christopher Piorkowski, MD · Herzzentrum Dresden GmbH Universitätsklinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-15
Primary Completion
2018-10-15
Completion
2018-10-15

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907828 on ClinicalTrials.gov