A(f)MAZE-CABG Study (AFMAZE-CABG)

Abbott

Status

Terminated

Conditions

Coronary Artery Bypass Graft Surgery

Atrial Fibrillation

Coronary Arteriosclerosis

Treatments

Device: HIFU AF Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00735722

AF07004AF

Details and patient eligibility

About

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.

Full 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.

Enrollment

188 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.