TerminatedNot Applicable

A(f)MAZE-CABG Study

Stopped: Insufficient recruitment

Canada, Finland, Germany188 participantsStarted 2009-07

Plain-language summary

Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG treated with best medical treatment according to ACC/AHA/ESC 2006 guidelines and no AF ablation.

Who can participate

Age range

18 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: * Legal age in host country * Scheduled for CABG surgery * Patient suffering from persistent or long-standing persistent AF * Patients having the ability to fully comply with the study requirements * Life expectancy \> 2 years * Patients who have given written informed consent to participate in the study Exclusion Criteria: * Clinically significant local or systemic infection or active endocarditis * Sutures, pacing/defibrillator leads on the left side of the heart, valve prostheses or rings, or other implanted material in or adjacent to target treatment area. * Stent in the coronary artery preventing an adequate mitral line * Any other concomitant operation on the heart * Previous heart surgery * Patients who are or may potentially be pregnant * Previous catheter ablation for atrial arrhythmia * LA size more than 60 mm in apical view on Trans-Thoracic Echocardiogram (TTE) * LA thrombus on intra-operative Trans-Oesophageal Echocardiogram (TOE) * Known contraindication to Amiodarone * Inability to undergo TOE * Patients who are unable to give full informed consent for the study.

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

Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months

Timeframe: 12 months

Trial details

NCT IDNCT00735722

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Coronary Arteriosclerosis trials