Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PROMISED, CPVI and LAAC, Radiofrequency ablation catheter, left atrial appendage occlusion device.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Atrial Fibrillation, Persistent. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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.
Overview
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.
Detailed description
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).
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 th - 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
Primary outcome measures
- Recurrence of atrial arrhythmia after a single ablation procedure. [Time frame: 12 months after the first procedure]
Secondary outcome measures (11)
- Recurrence of AF after a single ablation procedure [Time frame: 12 months after the first procedure]
- Recurrence of atrial flutter/atrial tachycardia after a single ablation [Time frame: 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 [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 [Time frame: 12 months after the first procedure]
- Incidence of periprocedural complications [Time frame: period of Post-operative to hospital discharge]
- post-procedure complications [Time frame: 12 months after the first procedure]
- Procedure duration of three-dimensional reconstruction of the left atrial [Time frame: At the end of the first procedure]
- Procedure duration at ablation [Time frame: At the end of the first procedure]
- Procedure duration at LAAC [Time frame: At the end of the first procedure]
- Incidence of events including device-related thrombus and peri-device leak at 3 months post-procedure [Time frame: 3 months after the first procedure]
- Anticoagulant discontinuation rate at 6 months post-procedure [Time frame: 6 months after the first procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou
Identifiers
NCT: NCT06249347 · SAHoWMU-CR2024-01-104