Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVI; Procedure: LA linear ablation; Procedure: CFAE ablation; Procedure: linear ablation; Device: CARTO

• Registration Number: NCT02929836
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-11
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20
• Primary Completion: 2017-05
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with longstanding persistent atrial fibrillation (lasting for>1 year)
• Exhibited refractoriness to at least one antiarrhythmic drug
• Left atrial diameter <=60mm

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Exclusion Criteria

• Patients with uncontrolled congestive heart failure
• Having significant valvular disease and/or prosthetic heart valve(s)
• With myocardial infarction or stroke within 6 months of screening
• With Significant congenital heart disease;ejection fraction was <40% measured by echocardiography
• Allergic to contrast media
• Contraindication to warfarin or heparin
• Severe pulmonary disease e.g. restrictive pulmonary disease
• Chronic obstructive disease (COPD)
• Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography
• Having any contraindication to right or left sided heart catheterization
• Poor general health
• Life expectancy less than 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI+linear ablation +CFAE ablation	LA linear ablation	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
PVI+linear ablation +CFAE ablation	linear ablation	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
PVI+LA linear ablation +CFAE ablation	PVI	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
PVI+LA linear ablation +CFAE ablation	LA linear ablation	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
PVI+LA linear ablation +CFAE ablation	CFAE ablation	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
PVI+linear ablation +CFAE ablation	CFAE ablation	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
PVI+linear ablation +CFAE ablation	CARTO	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
PVI+LA linear ablation +CFAE ablation	CARTO	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
PVI+CFAE ablation	PVI	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.
PVI+CFAE ablation	CARTO	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.
PVI+linear ablation +CFAE ablation	PVI	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
PVI+CFAE ablation	CFAE ablation	The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.

Primary Outcome Measures

Name	Time	Method
Time to first documented recurrence of atrial arrhythmias	2-year follow-up	Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure

Secondary Outcome Measures

Name	Time	Method
Number of redo procedures	2-year follow-up	Number of redo procedures，including two or more procedures
Procedure duration at ablation	At the end of the first ablation procedure	Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter
Ablation time at ablation	At the end of the first ablation procedure ]	Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery
Fluoroscopy time at ablation	At the end of the first ablation procedure	Minutes of fluoroscopy used during the entire ablation procedure
Complications	2-year follow-up	Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
Type of recurrent arrhythmia	2-year follow-up	Specific type of recurrent atrial arrhythmia

Trial Locations

Locations (1)

Shanghai chest hospital; 🇨🇳 Shanghai, Shanghai, China