NCT06952023Not yet recruiting
PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF
Pulsed Field-Based Bi-atrial Maze-like Catheter Ablation Versus Pulmonary Vein Isolation in Persistent Atrial Fibrillation: A Multi-center Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In radiofrequency (RF) ablation of persistent atrial fibrillation (PeAF), the additional linear ablation beyond pulmonary vein isolation (PVI) does not yield an reduce atrial arrhythmias recurrences.The goal of this clinical trial is to evaluate the efficiency of pulsed filed (PF) energy-based bi-atrial modified Maze ablation vs PF energy-based PVI of PeAF. The main questions it aims to answer are: Does PF energy effectively perform linear ablation in the left atrium? Does PFA-based bi-atrial modified Maze ablation significantly improve the success rate of PeAF ablation compared with PFA-based PVI? Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI only) in a 1:1 ratio. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- First submitted
- 23 Apr 2025
- Start date
- Jun 2025
- Primary completion date
- May 2027
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Diseases
- Atrial fibrillation
- NCT number
- NCT06952023
What you commit to
- Study type: Interventional
- Planned participants: 390
- From Jun 2025 to the primary completion date, May 2027
- 3 sites 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
- has received catheter ablation procedure for AF or atrial septal defect repair before enrollment
- refused to participate in this trial; or those who have participated in other clinical drug trials within 3 months prior to enrollment
Other illness
- left atrial diameter ≥55 mm or thrombosis in the left atrium
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack)
- acute or severe systemic infection
Lab values
- eGFR\<30mL/min/1.73m2
- congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio \> 1.5 or partial activated prothrombin time prolonged by ≥ 10 seconds, or plasma prothrombin time prolonged by ≥ 3 seconds, or fibrinogen ≤ 1.5 g/L), or active bleeding
Other
- PaAF or PeAF with duration \< 1 year
- pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
- life expectancy \< 12 months
Who the study is looking for
- Patients diagnosed with symptomatic PeAF at 18-75 years old who are eligible for the PFA procedure, and have any the following documentation, within 180 days of randomization of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days，OR iii. physician note of persistent continuous AF for \> 7 days
- The duration of AF lasting ≥ 1 year
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Jiangsu Provincial Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Affiliated Hospital Of Medical School Of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.