NCT06249347Recruiting
Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.
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.
Source: ClinicalTrials.gov · Last updated 12 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 8 Jan 2024
- Start date
- 28 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Diseases
- Atrial fibrillation
- NCT number
- NCT06249347
What you commit to
- Study type: Interventional
- Planned participants: 166
- From 28 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous atrial fibrillation ablation
Other illness
- Scheduled cardiac surgical intervention.
Age
- persistent AF that lasts \>10 years
Other
- Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;
- Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
- Life expectancy less than 1 year
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.