A(f)MAZE-CABG Study

Not Applicable

Terminated

• Conditions: Coronary Arteriosclerosis; Atrial Fibrillation; Coronary Artery Bypass Graft Surgery
• Interventions: Device: HIFU AF Ablation

• Registration Number: NCT00735722
• Lead Sponsor: Abbott Medical Devices

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 persistent AF undergoing CABG treated with best medical treatment according to ACC/AHA/ESC 2006 guidelines and no AF ablation.

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 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 Timeline

• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Study Start: 2009-07
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concomitant HIFU ablation	HIFU AF Ablation	HIFU AF Ablation

Primary Outcome Measures

Name	Time	Method
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life measurements (SF-36)	24 months
Effect of autonomic ganglia stimulation pre and post ablation intra-operatively	Discharge
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
Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay	24 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
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

Trial Locations

Locations (10)

Herzzentrum Essen; 🇩🇪 Essen, North Rhine-Westphalia, Germany

Universitatsklinikum Schleswig Holstein Campus Luebeck; 🇩🇪 Luebeck, Schleswig-Holstein, Germany

Derriford Hospital; 🇬🇧 Plymouth, Devon, United Kingdom

Tampere University Hospital; 🇫🇮 Tampere, Western Finland, Finland

Southampton University Hospital; 🇬🇧 Southampton, Hampshire, United Kingdom

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Rikshospitalet; 🇳🇴 Oslo, Norway

Feiringklinikken; 🇳🇴 Feiring, Norway

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Queen Elisabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada