Atrial Fibrillation, Atrial Fibrillation, Persistent
Conditions
Keywords
non-paroxysmal atrial fibrillation, left atrial anterior wall ablation, roof linear ablation, mitral isthmus linear ablation
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).
Interventions
PROCEDUREPROMISED
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.
PROCEDURECPVI 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
DEVICEleft atrial appendage occlusion device
Device： left atrial appendage occlusion device
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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) |
| 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. |
| 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) |
| 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 |
| 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 |
| Anticoagulant discontinuation rate at 6 months post-procedure | 6 months after the first procedure | Anticoagulant discontinuation rate at 6 months post-procedure |
| 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 |
Countries
China
Contacts
Primary ContactYue-chun Li, MD
Backup ContactYuan-nan Lin, MD
Outcome results
None listed