Clinical trial NCT00735722: A(f)MAZE-CABG Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Arteriosclerosis
Atrial Fibrillation
Coronary Artery Bypass Graft Surgery
Keywords: AF
CAD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:

* 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.

Primary outcomes:
measure: Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor)
timeFrame: 18 months
measure: Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)
timeFrame: 24 months
measure: AF burden (determined by 24 and 72 hour Holter monitor).
timeFrame: 24 months
measure: Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay
timeFrame: 24 months
measure: Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death
timeFrame: 24 months
measure: LV function and dimensions and LA size/transport capability
timeFrame: 24 months
measure: Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines
timeFrame: At intervention
measure: Effect of autonomic ganglia stimulation pre and post ablation intra-operatively
timeFrame: Discharge
measure: Quality of life measurements (SF-36)
timeFrame: 24 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elisabeth II Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Western Finland
city: Essen
country: Germany
facility: Herzzentrum Essen
state: North Rhine-Westphalia
city: Luebeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein Campus Luebeck
state: Schleswig-Holstein
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Feiring
country: Norway
facility: Feiringklinikken
city: Oslo
country: Norway
facility: Rikshospitalet
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
state: Hampshire
Study officials:
affiliation: Derriford Hospital, Plymouth, United Kingdom
name: Malcolm Dalrymple-Hay, Mr.
role: PRINCIPAL_INVESTIGATOR
References: