NCT02929836

Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.

Detailed description

Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	PVI	PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.
PROCEDURE	LA linear ablation	LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).
PROCEDURE	CFAE ablation	Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.
PROCEDURE	linear ablation	Right atrial CTI ablation was performed during SR.
DEVICE	CARTO	3 dimensional mapping system

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2018-10-01
• First posted: 2016-10-11
• Last updated: 2016-10-20

Locations

1 site across 1 country: China