A Prospective Randomized Trial Comparing Freedom From Atrial Fibrillation at One Year Post CABG in Patients Undergoing Concomitant Left Atrial Ablation Using High Intensity Focused Ultrasound (HIFU) Versus CABG in Patients With Persistent or Long Standing Persistent Atrial Fibrillation - Full Text View

A Prospective Randomized Trial Comparing Freedom From Atrial Fibrillation at One Year Post CABG in Patients Undergoing Concomitant Left Atrial Ablation Using High Intensity Focused Ultrasound (HIFU) Versus CABG in Patients With Persistent or Long Standing Persistent Atrial Fibrillation (A(f)MAZE-CABG)

This study is not yet open for participant recruitment.

Verified by St. Jude Medical, August 2008

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00735722

Purpose

Hypothesis

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.

Condition	Intervention
Coronary Arteriosclerosis Atrial Fibrillation Coronary Artery Bypass Graft Surgery	Device: HIFU AF Ablation Drug: Best Medical Therapy according to guidelines

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:

Interventional

Further study details as provided by St. Jude Medical:

Arms	Assigned Interventions
A: Active Comparator	Device: HIFU AF Ablation
B: No Intervention	Drug: Best Medical Therapy according to guidelines

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735722

Contacts

Contact: Silvia Mora

+3227746811

smora@sjm.com

Locations

United Kingdom, Devon
Derriford Hospital
Plymouth, Devon, United Kingdom

Sponsors and Collaborators

St. Jude Medical

More Information

Study ID Numbers:	AF07004AF
Study First Received:	August 14, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00735722
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by St. Jude Medical:

AF
CAD

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Atrial Fibrillation
Arteriosclerosis
Coronary Artery Disease
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009