A(f)MAZE-CABG Study

NCT00735722 | Terminated DMC

• 1 other identifier: AF07004AF
• Study Type: interventional
• Target: 188
• Locations: 6 countries
• Sites: 10

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.

Conditions

Coronary Arteriosclerosis; Atrial Fibrillation; Coronary Artery Bypass Graft Surgery

Keywords

AF; CAD

Outcome Measures

Primary Outcomes (1)

• Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months

  12 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Concomitant HIFU ablation

ACTIVE COMPARATOR

HIFU AF Ablation

Device: HIFU AF Ablation

Best medical treatment

NO INTERVENTION

Best medical treatment

Interventions

HIFU AF Ablation DEVICE

Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)

Also known as: • Epicor™ UltraCinch™ LP Ablation Device, • Epicor™ UltraWand™ LP Tissue Ablation Wand, • Epicor™ LP Positioning and Sizing (LP PAS™) System, • Epicor™ LP Oblique Introducer

Concomitant HIFU ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (10)

Queen Elisabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Tampere University Hospital

Tampere, Western Finland, 33520, Finland

Location

Herzzentrum Essen

Essen, North Rhine-Westphalia, 45138, Germany

Location

Universitatsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Feiringklinikken

Feiring, 2093, Norway

Location

Rikshospitalet

Oslo, 0027, Norway

Location

Derriford Hospital

Plymouth, Devon, United Kingdom

Location

Southampton University Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Malcolm Dalrymple-Hay, Mr.

  Derriford Hospital, Plymouth, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: July 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

FI (1); DE (2); NL (1); GB (2); CA (2); NO (2)