Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.

Atrial Fibrillation Clinical Trial

Official title:

Pulmonary Vein Isolation and Left Roof Linear, Mitral Isthmus Linear, and Left Anterior Septal Linear Ablation, and Left Atrial Appendage Device Occlusion in Patients With Non-paroxysmal Atrial Fibrillation: PROMISED Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249347
• Other study ID #: SAHoWMU-CR2024-01-104
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Yue-chun Li, MD
• Phone: +86-0577-8567-6610
• Email: liyuechun1980[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective randomized study is to assess whether a new treatment strategy consisting of circumferential Pulmonary vein isolation (PVI), left ROof linear (RL), Mitral Isthmus linear (MIL), and left anterior SEptal linear (ASL) ablation and left atrial appendage (LAA) Device occlusion (PROMISED procedure) is superior to the PVI combined LAA closure in enhancing the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation (AF) patients.

Description:

Circumferential pulmonary vein isolation (CPVI) is an important radiofrequency catheter ablation strategy for AF. The recurrence rate of non-paroxysmal AF (non-PAF) after CPVI remains unsatisfactory, despite the use of additional strategies, such as linear ablation and complex fractionated atrial electrogram ablation. Non-PAF initiation and maintenance depend on a critical mass, which allows reentry. The left atrial anterior wall contains a series of substrates that are associated with AF, such as low-voltage zones, Bachmann's bundle, and the LAA, which are important for AF initiation and maintenance. Combining CPVI with left RL, left ASL, and MIL ablation can create a box lesion set on the anterior wall which compartmentalize the left atrial anterior wall into small regions to modify the substrate. We hypothesized that this substrate modification strategy would improve the success rate of non-PAF ablation. However, functional damage to the LAA resulting from the above-mentioned ablation strategy may increase stroke risk. The combined use of AF ablation and LAA occlusion is safe and can reduce stroke risk. Therefore, we examined the safety, feasibility, and efficacy of a new treatment strategy for non-PAF, defined as the CPVI; left ROof linear, Mitral Isthmus linear, and left anterior SEptal linear ablation; and LAA Device occlusion (PROMISED) procedure. Cases were prospectively treated in a 2-arm 1:1 design according to ablation strategy, divided into the Promised group (n = 83) or the PVI combined LAAC group (n =83).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age > 18 years;

2. Persistent AF (AF duration > 7 days);

3. CHA2DS2-VASc score =2;

4. Presence of at least one of the following conditions:

• Unsuitable for long-term standardized anticoagulation therapy;
• Stroke or embolism still occurred based on long-term standardized anticoagulation therapy;
• HAS-BLED score =3;
• Unwillingness for long-term anticoagulation therapy;

Exclusion Criteria:

1. Previous atrial fibrillation ablation

2. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;

3. persistent AF that lasts >10 years

4. Scheduled cardiac surgical intervention.

5. Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction

6. Life expectancy less than 1 year

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Procedure:
• PROMISED
CPVI: Achievement of a wide disconnection of the right and left pulmonary veins; Roof linear ablation: linear ablation in the left atria roof; Anterior septal linear ablation: linear ablation in the anterior septal linear which coursed from the middle of the right superior and inferior pulmonary veins or the middle of the right superior pulmonary vein to the mitral valve annulus; Mitral isthmus linear ablation: linear ablation in the mitral isthmus; Left atrial appendage closure: Occlusion of the left atrial appendage with a left atrial appendage occlusion device.
• CPVI and LAAC
CPVI: Achievement of a wide disconnection of the right and left pulmonary veins; Left atrial appendage closure: Occlusion of the left atrial appendage with a left atrial appendage occlusion device.

Device:
• Radiofrequency ablation catheter
Device: Radiofrequency ablation catheter
• left atrial appendage occlusion device
Device: left atrial appendage occlusion device

Locations

Country	Name	City	State
China	Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial arrhythmia after a single ablation procedure.	Recurrence rate (percentage) of atrial fibrillation or atrial flutter or atrial tachycardia > 30 seconds after the blanking period of 3-month post ablation, at 1 year after a single ablation procedure. (use of antiarrhythmic medications was not allowed after the blanking period of 3-month)	12 months after the first procedure
Secondary	Recurrence of AF after a single ablation procedure	Recurrence rate (percentage) of AF> 30 seconds after the blanking period of 3 months post ablation, at 1 year after a single ablation procedure. (use of antiarrhythmic medications was not allowed after the blanking period of 3-month)	12 months after the first procedure
Secondary	Recurrence of atrial flutter/atrial tachycardia after a single ablation	Recurrence rate (percentage) of atrial flutter/atrial tachycardia> 30 seconds after the blanking period of 3 months post ablation, at 1 year after a single ablation procedure. (use of antiarrhythmic medications was not allowed after the blanking period of 3-month)	12 months after the first procedure
Secondary	Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate	Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate (excluding converted to sinus rhythm with cardioversion) and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate	12 months after the first procedure
Secondary	Occurrence of Intra-procedure Conversion from AF to Atrial Flutter or Atrial Tachycardia rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate	Occurrence of Intra-procedure Conversion from AF to Atrial Flutter or Atrial Tachycardia rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate	12 months after the first procedure
Secondary	Incidence of periprocedural complications	Incidence of periprocedural complications such as death, pericardial tamponade, stroke, occluder dislodgement, hemorrhage, esophageal injury, complications at access site (hematoma, arteriovenous fistula, pseudoaneurysm)	period of Post-operative to hospital discharge
Secondary	post-procedure complications	Incidence of post-procedure complications including death, stroke, major bleeding, cardiac tamponade, esophageal injury, and death.	12 months after the first procedure
Secondary	Procedure duration of three-dimensional reconstruction of the left atrial	Procedure duration of three-dimensional reconstruction of the left atrial	At the end of the first procedure
Secondary	Procedure duration at ablation	Procedure duration at ablation	At the end of the first procedure
Secondary	Procedure duration at LAAC	Procedure duration at LAAC	At the end of the first procedure
Secondary	Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure	Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure	3 months after the first procedure
Secondary	Anticoagulant discontinuation rate at 6 months post-procedure	Anticoagulant discontinuation rate at 6 months post-procedure	6 months after the first procedure