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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157807

Enrollment

Registered

2005-09-12

Start date

2005-09-30

Completion date

2013-08-31

Last updated

2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Coronary Artery Disease

Keywords

Persistent Atrial Fibrillation, Permanent Atrial Fibrillation, Mitral Valve Defect, Tricuspid Valve Defect, Aortic Valve Defect

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.

Interventions

PROCEDUREbipolar radiofrequency ablation of persistent and permanent AF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Quality of life	12 months
Cost of care	12 months

Secondary

Measure	Time frame
Atrial fibrillation	12 months
Echo parameters	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026