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

NCT06249347 | Recruiting

• 1 other identifier: SAHoWMU-CR2024-01-104
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation; Atrial Fibrillation, Persistent

Keywords

non-paroxysmal atrial fibrillation; left atrial anterior wall ablation; roof linear ablation; mitral isthmus linear ablation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial arrhythmia after a single ablation 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)

  12 months after the first procedure

Secondary Outcomes (11)

• Recurrence of AF after a single ablation procedure

  12 months after the first procedure

• Recurrence of atrial flutter/atrial tachycardia after a single ablation

  12 months after the first procedure

• Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate

  12 months after the first procedure

• Occurrence of Intra-procedure Conversion from AF to Atrial Flutter or Atrial Tachycardia rate and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate

  12 months after the first procedure

• Incidence of periprocedural complications

  period of Post-operative to hospital discharge

Study Arms (2)

PROMISED

EXPERIMENTAL

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)

Procedure: PROMISED; Device: Radiofrequency ablation catheter; Device: left atrial appendage occlusion device

CPVI and LAAC

ACTIVE COMPARATOR

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

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

Interventions

PROMISED PROCEDURE

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.

PROMISED

CPVI and LAAC PROCEDURE

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.

CPVI and LAAC

Radiofrequency ablation catheter DEVICE

Device： Radiofrequency ablation catheter

CPVI and LAAC; PROMISED

left atrial appendage occlusion device DEVICE

Device： left atrial appendage occlusion device

CPVI and LAAC; PROMISED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Persistent AF (AF duration \> 7 days);
• CHA2DS2-VASc score ≥2;
• 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;

You may not qualify if:

• 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.
• Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
• Life expectancy less than 1 year

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yue-chun Li, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue-chun Li, MD

CONTACT

+86-0577-8567-6610; liyuechun1980@sina.com

Yuan-nan Lin, MD

CONTACT

+86-0577-8567-6610; 597049712@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 8, 2024
• Study Start: January 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CN (1)