Catheter Ablation of Longstanding Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929836
• Other study ID #: DSL-20161002
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2016
• Last updated: October 19, 2016
• Start date: May 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2016
• Source: Shanghai Chest Hospital
• Contact: Yuanlong Mr Wang, MD
• Phone: 08615800719348
• Email: sdzhilong2011[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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).
• 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.
• linear ablation
Right atrial CTI ablation was performed during SR.

Device:
• CARTO
3 dimensional mapping system

Locations

Country	Name	City	State
China	Shanghai chest hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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 ]	No
Secondary	Fluoroscopy time at ablation	Minutes of fluoroscopy used during the entire ablation procedure	At the end of the first ablation procedure	No
Secondary	Complications	Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.	2-year follow-up	Yes
Secondary	Type of recurrent arrhythmia	Specific type of recurrent atrial arrhythmia	2-year follow-up	No
Secondary	Number of redo procedures	Number of redo procedures,including two or more procedures	2-year follow-up	No