Status:
TERMINATED
A(f)MAZE-CABG Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Arteriosclerosis
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
Primary Objective • To compare the efficacy of concomitant AF ablation using HIFU to no ablation at 12 months in patients with persistent or long standing persistent AF undergoing CABG according to A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00735722
Start Date
July 1 2009
End Date
August 1 2012
Last Update
February 4 2019
Active Locations (10)
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1
Queen Elisabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
3
Tampere University Hospital
Tampere, Western Finland, Finland, 33520
4
Herzzentrum Essen
Essen, North Rhine-Westphalia, Germany, 45138