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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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 criteria

Qualifiers

Age > 18 years;

Persistent AF (AF duration > 7 days);

CHA2DS2-VASc score ≥2;

Unsuitable for long-term standardized anticoagulation therapy;

Disqualifiers

Previous atrial fibrillation ablation

Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;

persistent AF that lasts >10 years

Scheduled cardiac surgical intervention.

Trial design

Treatments tested in this trial

  • PROMISED
  • CPVI and LAAC
  • Radiofrequency ablation catheter
  • left atrial appendage occlusion device

Treatment groups

166 Participants
are divided into 2 treatment groups