Atrial Fibrillation
Conditions
Keywords
atrial, fibrillation, pvi, vats, ablation, hybrid
Brief summary
Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.
Interventions
PROCEDUREEpicardial (surgical) ablation
* Pulmonary vein isolation with bipolar clamps and bipolar box lesion * Epicardial atrial appendage closure
PROCEDUREHybrid
Epicardial (surgical) ablation * Pulmonary vein isolation with bipolar clamps and bipolar box lesion * Epicardial atrial appendage closure Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation
Sponsors
Medisch Spectrum Twente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients are screened and accepted for pulmonary vein isolation according to the current guidelines * long standing persistent or persistent AF as defined in the guidelines * left atrial size needs to be more than \>46 mm on long axis or \>35 cc/m2 * CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.
Exclusion criteria
* Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed. * Previous PVI ablation (epicardial or endocardial) or cardiac surgery. * Significant valvular disease present on echo. * Concomitant cardiac surgery needed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation Freedom | 12 months | left sided atrial flutter and left atrial tachycardia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-isolation | 8-10 weeks | number of pulmonary veins needing re-isolation by the EP |
| Percentage of cross-over | 1 year | Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation. |
| Complications | 1 year | Number of complications and thrombo-embolic events in both groups |
| Atrial fibrillation Burden | 1 year | Burden of AF in both groups if AF is still present. |
Countries
Netherlands
Outcome results
None listed