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NCT Number: NCT06249347

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Circumferential pulmonary vein isolation (CPVI) is an important radiofrequency catheter ablation strategy for AF. The recurrence rate of non-paroxysmal AF (non-PAF) after CPVI remains unsatisfactory, despite the use of additional strategies, such as linear ablation and complex fractionated atrial electrogram ablation. Non-PAF initiation and maintenance depend on a critical mass, which allows reentry. The left atrial anterior wall contains a series of substrates that are associated with AF, such as low-voltage zones, Bachmann's bundle, and the LAA, which are important for AF initiation and maintenance. Combining CPVI with left RL, left ASL, and MIL ablation can create a box lesion set on the anterior wall which compartmentalize the left atrial anterior wall into small regions to modify the substrate. We hypothesized that this substrate modification strategy would improve the success rate of non-PAF ablation. However, functional damage to the LAA resulting from the above-mentioned ablation strategy may increase stroke risk. The combined use of AF ablation and LAA occlusion is safe and can reduce stroke risk. Therefore, we examined the safety, feasibility, and efficacy of a new treatment strategy for non-PAF, defined as the CPVI; left ROof linear, Mitral Isthmus linear, and left anterior SEptal linear ablation; and LAA Device occlusion (PROMISED) procedure. 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Radiofrequency ablation catheter

Device

Device: Radiofrequency ablation catheter

left atrial appendage occlusion device

Device

Device: left atrial appendage occlusion device

Primary outcomes

  1. Recurrence of atrial arrhythmia after a single ablation procedure.

    Time frame: 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)

Secondary outcomes

  1. Recurrence of AF after a single ablation procedure

    Time frame: 12 months after the first procedure

    Recurrence rate (percentage) of AF> 30 seconds after the blanking period of 3 months post ablation, at 1 year after a single ablation procedure. (use of antiarrhythmic medications was not allowed after the blanking period of 3-month)

  2. Recurrence of atrial flutter/atrial tachycardia after a single ablation

    Time frame: 12 months after the first procedure

    Recurrence rate (percentage) of atrial flutter/atrial tachycardia> 30 seconds after the blanking period of 3 months post ablation, at 1 year after a single ablation procedure. (use of antiarrhythmic medications was not allowed after the blanking period of 3-month)

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

    Time frame: 12 months after the first procedure

    Occurrence of Intra-procedure conversion of persistent AF to sinus rhythm rate (excluding converted to sinus rhythm with cardioversion) and Its Relationship to 1-Year Sinus Rhythm Maintenance Rate

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

    Time frame: 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

  5. Incidence of periprocedural complications

    Time frame: period of Post-operative to hospital discharge

    Incidence of periprocedural complications such as death, pericardial tamponade, stroke, occluder dislodgement, hemorrhage, esophageal injury, complications at access site (hematoma, arteriovenous fistula, pseudoaneurysm)

  6. post-procedure complications

    Time frame: 12 months after the first procedure

    Incidence of post-procedure complications including death, stroke, major bleeding, cardiac tamponade, esophageal injury, and death.

  7. Procedure duration of three-dimensional reconstruction of the left atrial

    Time frame: At the end of the first procedure

    Procedure duration of three-dimensional reconstruction of the left atrial

  8. Procedure duration at ablation

    Time frame: At the end of the first procedure

    Procedure duration at ablation

  9. Procedure duration at LAAC

    Time frame: At the end of the first procedure

    Procedure duration at LAAC

  10. Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure

    Time frame: 3 months after the first procedure

    Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure

  11. Anticoagulant discontinuation rate at 6 months post-procedure

    Time frame: 6 months after the first procedure

    Anticoagulant discontinuation rate at 6 months post-procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan-nan Lin, MD

CONTACT

[email protected]

+86-0577-8567-6610

Yue-chun Li, MD

CONTACT

[email protected]

+86-0577-8567-6610

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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