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

NCT06249347 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Phase

Not applicable

Started

2024-01-28

Last updated

2024-02-12

Condition(s) studied

Atrial FibrillationAtrial Fibrillation, Persistent

Investigational drug(s) / intervention(s)

PROMISEDCPVI and LAACRadiofrequency ablation catheterleft atrial appendage occlusion device

PROMISED: 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.

CPVI 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.

Radiofrequency ablation catheter: Device： Radiofrequency ablation catheter

left atrial appendage occlusion device: Device： left atrial appendage occlusion device

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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)

Trial sites (1)

Facility	City	Region	Status
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06249347 on ClinicalTrials.gov ↗ ← All trials in China