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Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PVI

LA linear ablation

CFAE ablation

linear ablation

CARTO

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ablation Linear Lesions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shanghai chest hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

PVI+LA linear ablation +CFAE ablation

PVI+linear ablation +CFAE ablation

PVI+CFAE ablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedure duration at ablation

Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter

Ablation time at ablation

Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery

Fluoroscopy time at ablation

Minutes of fluoroscopy used during the entire ablation procedure

Complications

Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.

Type of recurrent arrhythmia

Specific type of recurrent atrial arrhythmia

Number of redo procedures

Number of redo procedures，including two or more procedures

Full Information

NCT ID

NCT02929836

First Posted

October 5, 2016

Last Updated

October 19, 2016

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02929836

Brief Title

Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Ablation Linear Lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PVI+LA linear ablation +CFAE ablation

Arm Type

Active Comparator

Arm Description

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

Arm Title

PVI+linear ablation +CFAE ablation

Arm Type

Active Comparator

Arm Description

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

Arm Title

PVI+CFAE ablation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PVI

Intervention Description

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

Intervention Name(s)

LA linear ablation

Intervention Description

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

Intervention Name(s)

CFAE ablation

Intervention Description

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

Intervention Name(s)

linear ablation

Intervention Description

Right atrial CTI ablation was performed during SR.

Intervention Type

Device

Intervention Name(s)

CARTO

Intervention Description

3 dimensional mapping system

Primary Outcome Measure Information:

Title

Time to first documented recurrence of atrial arrhythmias

Description

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

Time Frame

2-year follow-up

Secondary Outcome Measure Information:

Title

Procedure duration at ablation

Description

Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter

Time Frame

At the end of the first ablation procedure

Title

Ablation time at ablation

Description

Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery

Time Frame

At the end of the first ablation procedure ]

Title

Fluoroscopy time at ablation

Description

Minutes of fluoroscopy used during the entire ablation procedure

Time Frame

At the end of the first ablation procedure

Title

Complications

Description

Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.

Time Frame

2-year follow-up

Title

Type of recurrent arrhythmia

Description

Specific type of recurrent atrial arrhythmia

Time Frame

2-year follow-up

Title

Number of redo procedures

Description

Number of redo procedures，including two or more procedures

Time Frame

2-year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuanlong Mr Wang, MD

Phone

08615800719348

sdzhilong2011@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Mr Liu, MD

Organizational Affiliation

Shanghai Chest Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai chest hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xu Liu, MD

Phone

08613017321303

xkliuxuchest@163.com

12. IPD Sharing Statement

Plan to Share IPD

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Catheter Ablation of Longstanding Persistent Atrial Fibrillation

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