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

Second Affiliated Hospital of Wenzhou Medical University

Status: Enrolling

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation

Treatments: Procedure: CPVI and LAAC; Procedure: PROMISED; Device: Radiofrequency ablation catheter; Device: left atrial appendage occlusion device

Study type: Interventional

Funder types: Other

Identifiers

NCT06249347

SAHoWMU-CR2024-01-104

Details and patient eligibility

About

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.

Full 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).

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

PROMISED

Experimental group

Description:

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)

Treatment:

Procedure: PROMISED

Device: Radiofrequency ablation catheter

Device: left atrial appendage occlusion device

CPVI and LAAC

Active Comparator group

Description:

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

Treatment:

Device: Radiofrequency ablation catheter

Procedure: CPVI and LAAC

Device: left atrial appendage occlusion device