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

NCT06249347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-02-12

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

PROCEDURE

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.

DEVICE

Radiofrequency ablation catheter

Device： Radiofrequency ablation catheter

DEVICE

left atrial appendage occlusion device

Device： left atrial appendage occlusion device

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Yue-chun Li, MD · Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-28
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249347 on ClinicalTrials.gov