Catheter Ablation of Longstanding Persistent Atrial Fibrillation

NCT ID: NCT02929836

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PVI+LA linear 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.

Group Type ACTIVE_COMPARATOR

PVI

Intervention Type PROCEDURE

PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.

LA linear ablation

Intervention Type PROCEDURE

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).

CFAE ablation

Intervention Type PROCEDURE

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.

CARTO

Intervention Type DEVICE

3 dimensional mapping system

PVI+linear 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.

Group Type ACTIVE_COMPARATOR

PVI

Intervention Type PROCEDURE

PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.

LA linear ablation

Intervention Type PROCEDURE

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).

CFAE ablation

Intervention Type PROCEDURE

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.

linear ablation

Intervention Type PROCEDURE

Right atrial CTI ablation was performed during SR.

CARTO

Intervention Type DEVICE

3 dimensional mapping system

PVI+CFAE ablation

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

Group Type ACTIVE_COMPARATOR

PVI

Intervention Type PROCEDURE

PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.

CFAE ablation

Intervention Type PROCEDURE

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.

CARTO

Intervention Type DEVICE

3 dimensional mapping system

Interventions

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PVI

PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.

Intervention Type 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).

Intervention Type 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.

Intervention Type PROCEDURE

linear ablation

Right atrial CTI ablation was performed during SR.

Intervention Type PROCEDURE

CARTO

3 dimensional mapping system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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wang yuanlong

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Mr Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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Shanghai chest hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuanlong Mr Wang, MD

Role: CONTACT

08615800719348

Facility Contacts

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Xu Liu, MD

Role: primary

08613017321303

Other Identifiers

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DSL-20161002

Identifier Type: -

Identifier Source: org_study_id

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