A(f)MAZE-CABG Study

Atrial Fibrillation Clinical Trial

— AFMAZE-CABG  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735722
• Other study ID #: AF07004AF
• Status: Terminated
• Phase: N/A
• Start date: July 2009
• Est. completion date: August 2012

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 188
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Atrial Fibrillation
• Coronary Arteriosclerosis
• Coronary Artery Bypass Graft Surgery
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)

Locations

Country	Name	City	State
Canada	Queen Elisabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Finland	Tampere University Hospital	Tampere	Western Finland
Germany	Herzzentrum Essen	Essen	North Rhine-Westphalia
Germany	Universitatsklinikum Schleswig Holstein Campus Luebeck	Luebeck	Schleswig-Holstein
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Norway	Feiringklinikken	Feiring
Norway	Rikshospitalet	Oslo
United Kingdom	Derriford Hospital	Plymouth	Devon
United Kingdom	Southampton University Hospital	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Canada,  Finland,  Germany,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months		12 months
Secondary	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
Secondary	Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)		24 months
Secondary	AF burden (determined by 24 and 72 hour Holter monitor).		24 months
Secondary	Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay		24 months
Secondary	Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death		24 months
Secondary	LV function and dimensions and LA size/transport capability		24 months
Secondary	Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines		At intervention
Secondary	Effect of autonomic ganglia stimulation pre and post ablation intra-operatively		Discharge
Secondary	Quality of life measurements (SF-36)		24 months