A(f)MAZE-CABG Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Arteriosclerosis, Atrial Fibrillation, Coronary Artery Bypass Graft Surgery

Intervention / Treatment
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* Device: HIFU AF Ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concomitant HIFU ablation<br>HIFU AF Ablation | Device: HIFU AF Ablation<br>* Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)<br>* Other names: • Epicor™ LP Oblique Introducer;|
| No Intervention: Best medical treatment<br>Best medical treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | 18 months | 
| Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor) |  | 24 months | 
| AF burden (determined by 24 and 72 hour Holter monitor). |  | 24 months | 
| Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay |  | 24 months | 
| Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death |  | 24 months | 
| LV function and dimensions and LA size/transport capability |  | 24 months | 
| Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines |  | At intervention | 
| Effect of autonomic ganglia stimulation pre and post ablation intra-operatively |  | Discharge | 
| Quality of life measurements (SF-36) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF, CAD