Clinical trial NCT06249347: Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation, Persistent
Keywords: non-paroxysmal atrial fibrillation
left atrial anterior wall ablation
roof linear ablation
mitral isthmus linear ablation
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of atrial arrhythmia after a single ablation procedure.
timeFrame: 12 months after the first procedure
Secondary outcomes:
measure: Recurrence of AF after a single ablation procedure
timeFrame: 12 months after the first procedure
measure: Recurrence of atrial flutter/atrial tachycardia after a single ablation
timeFrame: 12 months after the first procedure
measure: Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate
timeFrame: 12 months after the first procedure
measure: Occurrence of Intra-procedure Conversion from AF to Atrial Flutter or Atrial Tachycardia rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate
timeFrame: 12 months after the first procedure
measure: Incidence of periprocedural complications
timeFrame: period of Post-operative to hospital discharge
measure: post-procedure complications
timeFrame: 12 months after the first procedure
measure: Procedure duration of three-dimensional reconstruction of the left atrial
timeFrame: At the end of the first procedure
measure: Procedure duration at ablation
timeFrame: At the end of the first procedure
measure: Procedure duration at LAAC
timeFrame: At the end of the first procedure
measure: Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure
timeFrame: 3 months after the first procedure
measure: Anticoagulant discontinuation rate at 6 months post-procedure
timeFrame: 6 months after the first procedure
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
name: Yue-chun Li, MD
role: PRINCIPAL_INVESTIGATOR
References: