AFMAZE-CABG: A(f)MAZE-CABG Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
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To compare the safety of concomitant AF ablation using HIFU to no ablation in patients with persistent or long standing persistent AF undergoing CABG.
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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.
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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.
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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.
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To compare the morbidity associated with persistent or long standing persistent AF in patients following CABG and ablation compared to those receiving no ablation.
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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.
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To document the incidence of immediate post ablation bidirectional conduction block through the pulmonary venous cinch and mitral lines.
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To document the effect of Intra-operative pre and post ablation stimulation and ablation of the autonomic ganglia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Concomitant HIFU ablation HIFU AF Ablation |
Device: HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
Other Names:
|
| No Intervention: Best medical treatment Best medical treatment |
Outcome Measures
Primary Outcome Measures
- Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months [12 months]
Secondary Outcome Measures
- 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]
- LV function and dimensions and LA size/transport capability [24 months]
- Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines [At intervention]
- Effect of autonomic ganglia stimulation pre and post ablation intra-operatively [Discharge]
- Quality of life measurements (SF-36) [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Legal age in host country
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Scheduled for CABG surgery
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Patient suffering from persistent or long-standing persistent AF
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Patients having the ability to fully comply with the study requirements
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Life expectancy > 2 years
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Patients who have given written informed consent to participate in the study
Exclusion Criteria:
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Clinically significant local or systemic infection or active endocarditis
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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.
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Stent in the coronary artery preventing an adequate mitral line
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Any other concomitant operation on the heart
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Previous heart surgery
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Patients who are or may potentially be pregnant
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Previous catheter ablation for atrial arrhythmia
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LA size more than 60 mm in apical view on Trans-Thoracic Echocardiogram (TTE)
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LA thrombus on intra-operative Trans-Oesophageal Echocardiogram (TOE)
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Known contraindication to Amiodarone
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Inability to undergo TOE
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Patients who are unable to give full informed consent for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Elisabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 3A7 |
| 2 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 3 | Tampere University Hospital | Tampere | Western Finland | Finland | 33520 |
| 4 | Herzzentrum Essen | Essen | North Rhine-Westphalia | Germany | 45138 |
| 5 | Universitatsklinikum Schleswig Holstein Campus Luebeck | Luebeck | Schleswig-Holstein | Germany | 23562 |
| 6 | Catharina Ziekenhuis | Eindhoven | Noord-Brabant | Netherlands | 5623 EJ |
| 7 | Feiringklinikken | Feiring | Norway | 2093 | |
| 8 | Rikshospitalet | Oslo | Norway | 0027 | |
| 9 | Derriford Hospital | Plymouth | Devon | United Kingdom | |
| 10 | Southampton University Hospital | Southampton | Hampshire | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Malcolm Dalrymple-Hay, Mr., Derriford Hospital, Plymouth, United Kingdom
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AF07004AF