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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Recurrence of atrial arrhythmia after a single ablation procedure.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Previous atrial fibrillation ablation
- •Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;
- •persistent AF that lasts \>10 years
- •Scheduled cardiac surgical intervention.
- •Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
- •Life expectancy less than 1 year
Outcomes
Primary Outcomes
Recurrence of atrial arrhythmia after a single ablation procedure.
Time Frame: 12 months after the first 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)
Secondary Outcomes
- Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate(12 months after the first procedure)
- Recurrence of AF after a single ablation procedure(12 months after the first procedure)
- Recurrence of atrial flutter/atrial tachycardia after a single ablation(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(12 months after the first procedure)
- Incidence of periprocedural complications(period of Post-operative to hospital discharge)
- Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure(3 months after the first procedure)
- post-procedure complications(12 months after the first procedure)
- Procedure duration of three-dimensional reconstruction of the left atrial(At the end of the first procedure)
- Procedure duration at ablation(At the end of the first procedure)
- Procedure duration at LAAC(At the end of the first procedure)
- Anticoagulant discontinuation rate at 6 months post-procedure(6 months after the first procedure)