PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
| Condition(s) | Persistent Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF) |
| Who can participate | Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria: 1. Subjects with an age range of 18 years or above and 80 years or below. 2. Subjects have symptomatic, drug-resistant, persistent AF, defined as: 1. Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath. 2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD. 3. Persistent: continuous AF for \> 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart. 3. Subjects undergoing a first-ti |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Boston Scientific Corporation |
| Locations | Beijing, China |
| Start date | 2025-08-28 |
| NCT ID | NCT07106970 |
| Official listing | https://clinicaltrials.gov/study/NCT07106970 |