NCT00157807

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 8, 2025

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

September 8, 2005

Last Update Submit

May 5, 2025

Conditions

Atrial FibrillationCoronary Artery Disease

Keywords

Persistent Atrial FibrillationPermanent Atrial FibrillationMitral Valve DefectTricuspid Valve DefectAortic Valve Defect

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    12 months

  • Cost of care

    12 months

Secondary Outcomes (2)

  • Atrial fibrillation

    12 months

  • Echo parameters

    12 months

Study Arms (2)

No Ablation

NO INTERVENTION

bipolar radiofrequency ablation of persistent and permanent AF

OTHER

intra operative bipolar RF ablation of persistent and permanent AF

Procedure: bipolar radiofrequency ablation of persistent and permanent AF

Interventions

bipolar radiofrequency ablation of persistent and permanent AFPROCEDURE
bipolar radiofrequency ablation of persistent and permanent AF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Age \< 18 or \> 75 Years
  • Emergency surgery
  • Left dominant coronary circulation (relative contraindication)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinik für Herz-, Thorax- und Gefäßchirurgie

Lahr, Baden-Wurttemberg, 77933, Germany

Location

Klinikum der Universität Muenchen Großhadern Cardiac Surgery

München, Bavaria, 81377, Germany

Location

Klinik für Herz- und Thoraxchirurgie

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Klinik und Poliklinik für Herzchirurgie der Rhein. Friedrich-Wilhelms-Universität Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Klinik für Herz- und Thoraxchirurgie der Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony, 06120, Germany

Location

Related Links

MeSH Terms

Conditions

Atrial FibrillationCoronary Artery DiseaseAortic Valve Disease

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHeart Valve Diseases

Study Officials

  • Calin Vicol, Professor

    Klinikum der Universität München Großhadern Cardiac Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2008

Study Completion

August 1, 2013

Last Updated

May 8, 2025

Record last verified: 2017-02

Locations

DE(5)