Catheter Ablation of Longstanding Persistent Atrial Fibrillation

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI; Procedure: LA linear ablation; Procedure: CFAE ablation; Device: CARTO; Procedure: linear 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 Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuanlong Mr Wang, MD; Phone Number: 08615800719348; Email: sdzhilong2011@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Xu Liu, MD; Phone Number: 08613017321303; Email: xkliuxuchest@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Device: CARTO; 3 dimensional mapping system
Active Comparator: 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.	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.; Device: CARTO; 3 dimensional mapping system; Procedure: linear ablation; Right atrial CTI ablation was performed during SR.
Active Comparator: PVI+CFAE ablation; The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.	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: 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.; Device: CARTO; 3 dimensional mapping system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Principal Investigator: Xu Mr Liu, MD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 8, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Ablation Linear Lesions
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: DSL-20161002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No