Atrial Fibrillation Clinical Trial
— AFMAZE-CABGOfficial title:
A Prospective Randomized Trial Comparing Freedom From Atrial Fibrillation at One Year Post CABG in Patients Undergoing Concomitant Left Atrial Ablation Using HIFU Versus CABG in Patients With Persistent or Long Standing Persistent AF
NCT number | NCT00735722 |
Other study ID # | AF07004AF |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2009 |
Est. completion date | August 2012 |
Verified date | January 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 188 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elisabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Finland | Tampere University Hospital | Tampere | Western Finland |
Germany | Herzzentrum Essen | Essen | North Rhine-Westphalia |
Germany | Universitatsklinikum Schleswig Holstein Campus Luebeck | Luebeck | Schleswig-Holstein |
Netherlands | Catharina Ziekenhuis | Eindhoven | Noord-Brabant |
Norway | Feiringklinikken | Feiring | |
Norway | Rikshospitalet | Oslo | |
United Kingdom | Derriford Hospital | Plymouth | Devon |
United Kingdom | Southampton University Hospital | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Canada, Finland, Germany, Netherlands, Norway, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months | 12 months | ||
Secondary | Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor) | 18 months | ||
Secondary | Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor) | 24 months | ||
Secondary | AF burden (determined by 24 and 72 hour Holter monitor). | 24 months | ||
Secondary | Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay | 24 months | ||
Secondary | Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death | 24 months | ||
Secondary | LV function and dimensions and LA size/transport capability | 24 months | ||
Secondary | Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines | At intervention | ||
Secondary | Effect of autonomic ganglia stimulation pre and post ablation intra-operatively | Discharge | ||
Secondary | Quality of life measurements (SF-36) | 24 months |
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