Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Ablation, Thoracoscopy, Atrial function
Brief summary
Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF. Secondary Objectives Does totally endoscopic ablation: * reduce atrial fibrillation symptoms? * increase working capacity and improve quality of life? * improve atrial function? * reduce the risk for stroke?
Detailed description
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.
Interventions
PROCEDUREEndoscopic 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.
DRUGRate 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.
Sponsors
Medtronic
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 50 years 2. Longstanding persistent AF of \> 1 year duration 3. Severe symptoms related to AF 4. Have signed and dated Informed Consent. 5. Willing and able to comply with the protocol for the duration of the trial.
Exclusion criteria
1. Severe ischemic heart disease or heart valve disease 2. Thrombus formation in left atrial appendage 3. Intolerance to warfarin medication 4. Advanced pulmonary disease, FEV 1 \< 1.5 litre 5. Left atrial diameter \> 60 mm 6. Body Mass Index (BMI) \> 35 kg/m2 7. Previous pulmonary or heart surgery 8. Participation in another clinical trial within the last 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs | 3-12 months |
Secondary
| Measure | Time frame |
|---|---|
| Freedom of symptomatic AF episodes 3 - 12 months | 3-12 months |
| Exercise capacity after 12 months | 12 months |
| Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months | 12 months |
| Atrial function and dimensions after 6 and 12 months | 12 months |
| Freedom of thromboembolic events during the study | 12 months |
Countries
Sweden
Outcome results
None listed