Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: Endocardial catheter ablation; Device: Implantable loop recorder; Procedure: Thoracoscopic epicardial ablation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01794416

TA-EA-001

Details and patient eligibility

About

The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• failed initial catheter ablation
• paroxysmal atrial fibrillation

Exclusion criteria

• chronic lung disease
• body mass index >35
• longstanding atrial fibrillation 1 year
• previous stroke or transient ischemic attack
• left atrial thrombus
• left atrial size >65 mm
• left ventricular ejection fraction <35%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Thoracoscopic epicardial ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: Thoracoscopic epicardial ablation

Device: Implantable loop recorder

Endocardial catheter ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: Endocardial catheter ablation

Device: Implantable loop recorder