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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Fibrillation, Persistent
• Intervention / Treatment: Procedure: PROMISED; Device: Radiofrequency ablation catheter; Device: left atrial appendage occlusion device; Procedure: CPVI and LAAC

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue-chun Li, MD; Phone Number: +86-0577-8567-6610; Email: liyuechun1980@sina.com
• Study Contact Backup: Name: Yuan-nan Lin, MD; Phone Number: +86-0577-8567-6610; Email: 597049712@qq.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
      • Contact: Yue-chun Li, MD; Phone Number: +86-0577-8567-6610; Email: liyuechun1980@sina.com
      • Contact: Yuan-nan Lin, MD; Phone Number: +86-0577-8567-6610; Email: 597049712@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROMISED; Guided by a circular mapping catheter, all patients initially underwent wide-area circumferential pulmonary vein isolation (CPVI) using radiofrequency ablation catheter. If sinus rhythm was restored after performing the CPVI ablation, the ablation procedure would be stopped. If AF persisted, patients underwent linear ablation (roof linear ablation+anterior septal linear ablation+mitral isthmus linear ablation) using radiofrequency ablation catheter. Then, guided by left atrial appendage (LAA) angiography, the operators selected an appropriately sized left atrial appendage occlusion device according to the LAA size and morphology. Interventions: Procedure: CPVI+ roof linear ablation + anterior septal linear ablation + mitral isthmus linear ablation + Left atrial appendage closure (LAAC)	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.; Device: Radiofrequency ablation catheter; Device： Radiofrequency ablation catheter; Device: left atrial appendage occlusion device; Device： left atrial appendage occlusion device
Active Comparator: CPVI and LAAC; Guided by a circular mapping catheter, all patients initially underwent wide-area CPVI using radiofrequency ablation catheter. Then, guided by LAA angiography, the operators selected an appropriately sized left atrial appendage occlusion device according to the LAA size and morphology. Interventions: Procedure: CPVI and LAAC	Device: Radiofrequency ablation catheter; Device： Radiofrequency ablation catheter; Device: left atrial appendage occlusion device; Device： left atrial appendage occlusion device; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Anticoagulant discontinuation rate at 6 months post-procedure	Anticoagulant discontinuation rate at 6 months post-procedure	6 months after the first procedure
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
Procedure duration at ablation	Procedure duration at ablation	At the end of the first procedure
Procedure duration at LAAC	Procedure duration at LAAC	At the end of the first procedure

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Yue-chun Li, MD, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: non-paroxysmal atrial fibrillation; left atrial anterior wall ablation; roof linear ablation; mitral isthmus linear ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SAHoWMU-CR2024-01-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No