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

Phase 2

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Thoracoscopic epicardial ablation; Procedure: Endocardial catheter ablation; Device: Implantable loop recorder

• Registration Number: NCT01794416
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-15
• Study First Posted: 2013-02-18
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-24
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracoscopic epicardial ablation	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.
Thoracoscopic epicardial ablation	Implantable loop recorder	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.
Endocardial catheter ablation	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.
Endocardial catheter ablation	Implantable loop recorder	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.

Primary Outcome Measures

Name	Time	Method
freedom from any atrial arrhythmia	12 months

Secondary Outcome Measures

Name	Time	Method
rate of significant adverse events (SAEs)	12 months
atrial fibrillation burden by ILR	12 months

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation