atrium fibrillation
Conditions
Interventions
Patient will undergo routine CABG. Before the CABG is performed the HIFU
ablation procedure is performed on the beating heart. The device used is the
Epicor UltraCinch LP Ablation Device. This is a
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months. One or more episode(s) (on a 72 hours Holter monitor) of AF, Atrial Flutter or Atrial Tachycardia lasting > 30 seconds will be regarded as recurrence of Atrial Arrhythmia according to the Guidelines for Reporting Data and Outcomes for the Surgical Treatment of Atrial Fibrillation . | — |
Secondary
| Measure | Time frame |
|---|---|
| • Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor) • Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor) • AF burden at baseline, 3, 6, 9, 12 18 and 24 months (determined by 24 and 72 hour Holter monitor). • Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay. • Incidence of stroke, TIA, PV stenosis, bleeding (any episode of major internal or external bleeding that causes death, hospitalization, operation, pericardiocentesis, or permanent injury (e.g. vision loss) or requires transfusion. A bleeding event is reportable whether or not the subject is taking anticoagulation or antiplatelet drugs), thromboembolic complications (not TIA), subsequent pace maker implantation, and death. • LV function and dimensions and LA size/transport capability at baseline, 6,12 and 24 months post operatively. • Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines. • Effect of autonomic ganglia stimulation pre and post ablation intra-operatively (measured by slowing of heart rate) • Quality of life measurements (SF-36) at baseline, 3, 6, 9, 12,18 and 24 months follow up. • Health Economic evaluation after 24 months including any intervention and its related costs; all AF-related direct medical costs in inpatient, outpatient and ambulatory setting; drug treatment costs; adverse event treatment costs. | — |
Countries
Netherlands
Outcome results
None listed