Totally Endoscopic Ablation of Atrial Fibrillation (TEA)
Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF.
Does totally endoscopic ablation:
- reduce atrial fibrillation symptoms?
- increase working capacity and improve quality of life?
- improve atrial function?
- reduce the risk for stroke?
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Totally Endoscopic Ablation of Atrial Fibrillation|
- Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]
- Freedom of symptomatic AF episodes 3 - 12 months [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]
- Exercise capacity after 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Atrial function and dimensions after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Freedom of thromboembolic events during the study [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
|Experimental: Endoscopic ablation of atrial fibrillation||
Procedure: Endoscopic ablation of AF
The procedure is conducted in general anaesthesia. The right chest is entered with three working ports .
After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care.
|Active Comparator: Rate control||
Drug: Rate control
Anti-arrhythmic protocol The control group is using a rate-control strategy. All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up. No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.
This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.
After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.
The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940056
|Örebro University Hospital|
|Örebro, Sweden, 70285|
|Principal Investigator:||Anders Ahlsson, MD PhD||Department of Cardiothoracic Surgery|
|Study Chair:||Espen Fengsrud, MD||Department of Cardiology|
|Study Director:||Anders Englund, MD PhD||Stockholm Arrhythmia Center|
|Study Chair:||Peter Linde, MD||Department of Cardiology|
|Study Chair:||Henrik Almroth, MD||Department of Cardiology|
|Study Chair:||Tommy Andersson, MD||Department of Cardiology|
|Study Chair:||Hans Tyden, MD PhD||Department of Cardiothoracic Surgery|