NCT02441738

Hybrid Versus Catheter Ablation in Persistent AF

Hybrid Thoracoscopic Surgical and Transvenous Catheter Ablation Versus Transvenous Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold. Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set. The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Hybrid Ablation	The procedure will be performed following standard of care guidelines.
PROCEDURE	Catheter Ablation	The procedure will be performed following standard of care guidelines.

Timeline

• Start date: 2016-10-31
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2015-05-12
• Last updated: 2019-05-16

Locations

1 site across 1 country: Netherlands