Status:
COMPLETED
Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
Heart Health Research Centre
The George Institute for Global Health, China
Conditions:
Persistent Atrial Fibrillation
Catheter Ablation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgra...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria Patients are to be excluded if any of the following criteria is met：
- 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,
- left ventricular ejection fraction (LVEF) \< 30%,
- 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 with contraindication to anticoagulation,
- patients with contraindication to right or left sided heart catheterization,
- pregnancy,
- life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
- patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
Exclusion
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT04497376
Start Date
August 27 2021
End Date
July 18 2024
Last Update
July 19 2024
Active Locations (12)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510235
3
Taizhou Hospital of Zhejiang Province
Taizhou, Hangzhou, China, 318050
4
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001