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.
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 ACC/AHA/ESC 2006 guidelines and HRS/EHRA/ECAS Consensus Statement on Catheter and Surgical Ablation . Secondary Objectives * To compare the safety of concomitant AF ablation using HIFU to no ablation in patients with persistent or long standing persistent AF undergoing CABG. * To compare AF burden in patients with persistent or long standing persistent AF treated with concomitant HIFU AF ablation undergoing CABG to those receiving no ablation. * To compare the quality of life of patients with persistent or long standing persistent AF treated with concomitant HIFU AF ablation undergoing CABG to those receiving no ablation. * To compare the health economic impact of concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG to those receiving no ablation. * To compare the morbidity associated with persistent or long standing persistent AF in patients following CABG and ablation compared to those receiving no ablation. * To compare cardiac function and left atrial transport associated with persistent or long standing persistent AF patients following CABG and ablation compared to those receiving no ablation. * To document the incidence of immediate post ablation bidirectional conduction block through the pulmonary venous cinch and mitral lines. * To document the effect of Intra-operative pre and post ablation stimulation and ablation of the autonomic ganglia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
188
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
Queen Elisabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Tampere University Hospital
Tampere, Western Finland, Finland
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months
Time frame: 12 months
Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor)
Time frame: 18 months
Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)
Time frame: 24 months
AF burden (determined by 24 and 72 hour Holter monitor).
Time frame: 24 months
Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay
Time frame: 24 months
Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death
Time frame: 24 months
LV function and dimensions and LA size/transport capability
Time frame: 24 months
Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines
Time frame: At intervention
Effect of autonomic ganglia stimulation pre and post ablation intra-operatively
Time frame: Discharge
Quality of life measurements (SF-36)
Time frame: 24 months
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Herzzentrum Essen
Essen, North Rhine-Westphalia, Germany
Universitatsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Feiringklinikken
Feiring, Norway
Rikshospitalet
Oslo, Norway
Derriford Hospital
Plymouth, Devon, United Kingdom
Southampton University Hospital
Southampton, Hampshire, United Kingdom