Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
188 participants
INTERVENTIONAL
2009-07-31
2012-08-31
Brief Summary
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Detailed Description
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• 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Concomitant HIFU ablation
HIFU AF Ablation
HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
Best medical treatment
Best medical treatment
No interventions assigned to this group
Interventions
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HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Malcolm Dalrymple-Hay, Mr.
Role: PRINCIPAL_INVESTIGATOR
Derriford Hospital, Plymouth, United Kingdom
Locations
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Queen Elisabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Tampere University Hospital
Tampere, Western Finland, Finland
Herzzentrum Essen
Essen, North Rhine-Westphalia, Germany
Universitatsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Feiringklinikken
Feiring, , Norway
Rikshospitalet
Oslo, , Norway
Derriford Hospital
Plymouth, Devon, United Kingdom
Southampton University Hospital
Southampton, Hampshire, United Kingdom
Countries
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Other Identifiers
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AF07004AF
Identifier Type: -
Identifier Source: org_study_id
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