A(f)MAZE-CABG Study (AFMAZE-CABG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00735722|
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : August 15, 2008
Last Update Posted : April 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis Atrial Fibrillation Coronary Artery Bypass Graft Surgery||Device: HIFU AF Ablation||Not Applicable|
• 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 .
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: Concomitant HIFU ablation
HIFU AF Ablation
Device: HIFU AF Ablation
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
No Intervention: Best medical treatment
Best medical treatment
- Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months [ Time Frame: 12 months ]
- Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor) [ Time Frame: 18 months ]
- Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor) [ Time Frame: 24 months ]
- AF burden (determined by 24 and 72 hour Holter monitor). [ Time Frame: 24 months ]
- Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay [ Time Frame: 24 months ]
- Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death [ Time Frame: 24 months ]
- LV function and dimensions and LA size/transport capability [ Time Frame: 24 months ]
- Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines [ Time Frame: At intervention ]
- Effect of autonomic ganglia stimulation pre and post ablation intra-operatively [ Time Frame: Discharge ]
- Quality of life measurements (SF-36) [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735722
|Canada, Nova Scotia|
|Queen Elisabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Tampere University Hospital|
|Tampere, Western Finland, Finland, 33520|
|Essen, North Rhine-Westphalia, Germany, 45138|
|Universitatsklinikum Schleswig Holstein Campus Luebeck|
|Luebeck, Schleswig-Holstein, Germany, 23562|
|Eindhoven, Noord-Brabant, Netherlands, 5623 EJ|
|Feiring, Norway, 2093|
|Oslo, Norway, 0027|
|Plymouth, Devon, United Kingdom|
|Southampton University Hospital|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Principal Investigator:||Malcolm Dalrymple-Hay, Mr.||Derriford Hospital, Plymouth, United Kingdom|