NCT04497376Completed
Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 19 Jul 2024
Brief summary (registry, in English)
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 498 (actual)
- First submitted
- 8 Jul 2020
- Start date
- 27 Aug 2021
- Primary completion date
- 18 Jul 2024
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT04497376
What you commit to
- Study type: Interventional
- Participants enrolled: 498
- From 27 Aug 2021 to the primary completion date, 18 Jul 2024
- 12 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
- patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
- patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
Other illness
- patients with contraindication to right or left sided heart catheterization,
- life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
Lab values
- left ventricular ejection fraction (LVEF) \< 30%,
Other
- patients with paroxysmal AF,
- patients with AF secondary to an obvious reversible cause,
- patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,
- patients with contraindication to anticoagulation,
- pregnancy,
Who the study is looking for
- Patients must meet all the following criteria to be included in the study:
- age between 18 and 80,
- patients undergoing a first-time ablation procedure for non-valvular AF,
- patients with defined as a sustained episode more than 3 months
- PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
- patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
- AF refractory to at least one AAD,
- willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Shengli Oilfield Central Hospital Coordinator of this site? Confirm its status | Dongying | China | Unknown status |
| Sun Yat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jiangsu Provincial Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Wuhan Asia Heart Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Fuwai Central China Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.