Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Shanghai Jiao Tong University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: LA linear ablation; Device: CARTO; Procedure: CFAE ablation; Procedure: linear ablation; Procedure: PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT02929836

DSL-20161002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 3 patient groups

PVI+LA linear ablation +CFAE ablation

Active Comparator group

Description:

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

Treatment:

Device: CARTO

Procedure: LA linear ablation

Procedure: CFAE ablation

Procedure: PVI

PVI+linear ablation +CFAE ablation

Active Comparator group

Description:

The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.

Treatment:

Device: CARTO

Procedure: LA linear ablation

Procedure: CFAE ablation

Procedure: PVI

Procedure: linear ablation

PVI+CFAE ablation

Active Comparator group

Description:

The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.

Treatment:

Device: CARTO

Procedure: CFAE ablation

Procedure: PVI