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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Atrial Fibrillation trials