RecruitingNot ApplicableNCT06249347

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

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.


Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Enrollment

166 participants

Start Date

Jan 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of heart procedure called catheter ablation with additional "line" burns inside the left atrium to treat persistent atrial fibrillation (an irregular heart rhythm lasting more than 7 days) in patients who are at high risk of stroke but either cannot or will not take blood thinners long-term. **You may be eligible if...** - You are over 18 years old - You have persistent atrial fibrillation lasting more than 7 days - You have a stroke risk score of 2 or more (CHA2DS2-VASc ≥2) - You are unable to take long-term blood thinners, or had a stroke despite being on them, or have a high bleeding risk, or simply do not want to take them long-term **You may NOT be eligible if...** - You have had a previous atrial fibrillation ablation procedure - Your left atrium is very enlarged (over 60mm) - Your AF has persisted for more than 10 years - You have a blood clot in your heart - You are scheduled for heart surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

DEVICERadiofrequency ablation catheter

Device: Radiofrequency ablation catheter

DEVICEleft atrial appendage occlusion device

Device: left atrial appendage occlusion device


Locations(1)

Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT06249347


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