Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

November 18, 2016 updated by: Boris Schmidt
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 15030
        • Na Homolce Hospital
  • Germany
      • Frankfurt/Main, Germany, 60431
        • Cardioangiologisches Centrum Bethanien
      • Karlsruhe, Germany, 76133
        • Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
    • Bavaria
      • Bad Neustadt, Bavaria, Germany, 97616
        • Herz- und Gefäß-Klinik GmbH Bad Neustadt
    • NRW
      • Bonn, NRW, Germany, 53105
        • Rheinische Friedrich-Wilhelms-Universität Bonn
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 80 years
  • persistent atrial fibrillation
  • failure of at least one antiarrhythmic drug
  • others

Exclusion Criteria:

  • contraindications for pulmonary vein isolation (PVI)
  • previous PVI attempts
  • inability to be treated with oral anticoagulation
  • presence of intracardiac thrombi
  • pregnancy
  • others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HeartLight(TM) Laser Balloon
Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)
Device: HeartLight(TM) Laser Balloon
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
Active Comparator: irrigated radiofrequency current ablation
Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation
Device: irrigated radiofrequency current ablation
The irrigated radiofrequency current ablation is used for pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
Time Frame: between day 90 and 365 days after index procedure
between day 90 and 365 days after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boris Schmidt

Investigators

  • Principal Investigator: Boris Schmidt, Dr., Cardioangiologisches Centrum Bethanien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 19, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF20/13 Version 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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