TerminatedNot Applicable

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

Stopped: no eligible patients can be found

Germany24 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Quality of life

Timeframe: 12 months

Cost of care

Timeframe: 12 months

Trial details

NCT IDNCT00157807

SponsorMedtronic Cardiac Surgery

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06