Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
- Conditions
- Atrial Fibrillation, PersistentAtrial Fibrillation
- Interventions
- Procedure: CPVI and LAACProcedure: PROMISEDDevice: Radiofrequency ablation catheterDevice: left atrial appendage occlusion device
- Registration Number
- NCT06249347
- Lead Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PROMISED Radiofrequency ablation catheter 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) CPVI and LAAC 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 PROMISED 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) PROMISED left atrial appendage occlusion device 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) CPVI and LAAC Radiofrequency ablation catheter 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 CPVI and LAAC left atrial appendage occlusion device 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
- Primary Outcome Measures
Name Time Method Recurrence of atrial arrhythmia after a single ablation procedure. 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 Outcome Measures
Name Time Method 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 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
Recurrence of AF after a single ablation procedure 12 months after the first 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)
Recurrence of atrial flutter/atrial tachycardia after a single ablation 12 months after the first procedure 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)
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 Occurrence of Intra-procedure Conversion from AF to Atrial Flutter or Atrial Tachycardia rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate
Incidence of periprocedural complications period of Post-operative to hospital discharge Incidence of periprocedural complications such as death, pericardial tamponade, stroke, occluder dislodgement, hemorrhage, esophageal injury, complications at access site (hematoma, arteriovenous fistula, pseudoaneurysm)
Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure 3 months after the first procedure Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure
post-procedure complications 12 months after the first procedure Incidence of post-procedure complications including death, stroke, major bleeding, cardiac tamponade, esophageal injury, and death.
Procedure duration of three-dimensional reconstruction of the left atrial At the end of the first procedure Procedure duration of three-dimensional reconstruction of the left atrial
Anticoagulant discontinuation rate at 6 months post-procedure 6 months after the first procedure Anticoagulant discontinuation rate at 6 months post-procedure
Procedure duration at ablation At the end of the first procedure Procedure duration at ablation
Procedure duration at LAAC At the end of the first procedure Procedure duration at LAAC
Trial Locations
- Locations (1)
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China