Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery

May 5, 2025 updated by: Medtronic Cardiac Surgery

Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery. A Prospective Randomized Multi Center Trial

The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. The study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. Furthermore, there will be thorough echocardiographic examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Germany
    • Baden Württemberg
      • Lahr, Baden Württemberg, Germany, 77933
        • Klinik für Herz-, Thorax- und Gefäßchirurgie
    • Bayern
      • München, Bayern, Germany, 81377
        • Klinikum der Universität Muenchen Großhadern Cardiac Surgery
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44789
        • Klinik für Herz- und Thoraxchirurgie
      • Bonn, Nordrhein-Westfalen, Germany, 53105
        • Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn
    • Sachsen
      • Halle, Sachsen, Germany, 06120
        • Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Persistent atrial fibrillation
  • Permanent atrial fibrillation
  • Mitral valve defect
  • Tricuspid valve defect
  • Aortic valve defect
  • Coronary artery disease

Exclusion Criteria:

  • Pregnancy
  • Age < 18 or > 75 Years
  • Emergency surgery
  • Left dominant coronary circulation (relative contraindication)
  • Coronary arteries of the posterior wall without pathological findings: No inclusion
  • Stenosis of the posterior wall vessels, supplied with a CABG (coronary artery bypass grafting): Inclusion possible
  • Left ventricular ejection fraction < 30%
  • Size of the left atrium > 7 cm
  • Thrombosis of the left atrial appendage
  • Leads in the coronary sinus
  • Atrial flutter
  • Infective endocarditis
  • Reoperation
  • Participation in other studies
  • Life expectancy of less than 12 months
  • Psychiatric disorders
  • Hyperthyreosis

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Ablation
Other: bipolar radiofrequency ablation of persistent and permanent AF
intra operative bipolar RF ablation of persistent and permanent AF
Procedure: bipolar radiofrequency ablation of persistent and permanent AF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 12 months
12 months
Cost of care
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Atrial fibrillation
Time Frame: 12 months
12 months
Echo parameters
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Surgery

Collaborators

Medtronic

Investigators

  • Principal Investigator: Calin Vicol, Professor, Klinikum der Universität München Großhadern Cardiac Surgery

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.

Helpful Links

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

September 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimated)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CS_1

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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