Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation
|Paroxysmal Atrial Fibrillation||Procedure: Thoracoscopic epicardial ablation Procedure: Endocardial catheter ablation Device: Implantable loop recorder||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation|
- freedom from any atrial arrhythmia [ Time Frame: 12 months ]
- rate of significant adverse events (SAEs) [ Time Frame: 12 months ]
- atrial fibrillation burden by ILR [ Time Frame: 12 months ]
|Study Start Date:||May 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Thoracoscopic epicardial ablation
Patients were treated with video-assisted thoracoscopy under general anesthesia. PVI was performed from the epicardial side with a bipolar RF ablation clamp (AtriCure). At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. An additional application was made in the interatrial Waterston groove in the right side to isolate the ganglionic plexi from the atria. On the left side, the ligament of Marshal was cut, but no additional ablation of ganglionic plexi was pursued.
The RevealXT (implantable loop recorder) was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
|Procedure: Thoracoscopic epicardial ablation Device: Implantable loop recorder|
Active Comparator: Endocardial catheter ablation
Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a ﬂow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster). The RevealXT (implantable loop recorder) was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
|Procedure: Endocardial catheter ablation Device: Implantable loop recorder|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794416
|State Research Institute of Circulation Pathology|
|Novosibirsk, Russian Federation, 630055|
|Principal Investigator:||Evgeny Pokushalov, MD, PhD||State Research Institute of Circulation Pathology|