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New treatment option for Atrial Fibrillation
Official title Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
ClinicalTrials.gov ID: NCT06249347
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join 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
See the full eligibility 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;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.