Catheter Ablation of Longstanding Persistent Atrial Fibrillation

NCT02929836 | Unknown DMC

• 1 other identifier: DSL-20161002
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Ablation Linear Lesions

Outcome Measures

Primary Outcomes (1)

• Time to first documented recurrence of atrial arrhythmias

  Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure

  2-year follow-up

Secondary Outcomes (6)

• Procedure duration at ablation

  At the end of the first ablation procedure

• Ablation time at ablation

  At the end of the first ablation procedure ]

• Fluoroscopy time at ablation

  At the end of the first ablation procedure

• Complications

  2-year follow-up

• Type of recurrent arrhythmia

  2-year follow-up

Study Arms (3)

PVI+LA linear ablation +CFAE ablation

ACTIVE COMPARATOR

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

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

PVI+linear ablation +CFAE ablation

ACTIVE COMPARATOR

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

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

PVI+CFAE ablation

ACTIVE COMPARATOR

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

Procedure: PVI; Procedure: CFAE ablation; Device: CARTO

Interventions

PVI PROCEDURE

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

PVI+CFAE ablation; PVI+LA linear ablation +CFAE ablation; PVI+linear ablation +CFAE ablation

LA linear ablation 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).

PVI+LA linear ablation +CFAE ablation; PVI+linear ablation +CFAE ablation

CFAE ablation 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.

PVI+CFAE ablation; PVI+LA linear ablation +CFAE ablation; PVI+linear ablation +CFAE ablation

linear ablation PROCEDURE

Right atrial CTI ablation was performed during SR.

PVI+linear ablation +CFAE ablation

CARTO DEVICE

3 dimensional mapping system

PVI+CFAE ablation; PVI+LA linear ablation +CFAE ablation; PVI+linear ablation +CFAE ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai chest hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xu Mr Liu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanlong Mr Wang, MD

CONTACT

08615800719348; sdzhilong2011@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 11, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 20, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)