Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation (PROMPT-AF)

Capital Medical University

Status: Completed

Conditions: Persistent Atrial Fibrillation; Catheter Ablation

Treatments: Procedure: upgraded '2C3L'; Procedure: pulmonary vein antral isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT04497376

2017YFC0908803

Details and patient eligibility

About

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.

Full 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 upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).

Enrollment: 498 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Patients must meet all the following criteria to be included in the study:

1. age between 18 and 80,
2. patients undergoing a first-time ablation procedure for non-valvular AF,
3. patients with defined as a sustained episode more than 3 months
4. PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
5. patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
6. AF refractory to at least one AAD,
7. 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：

1. patients with paroxysmal AF,
2. patients with AF secondary to an obvious reversible cause,
3. patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,
4. left ventricular ejection fraction (LVEF) < 30%,
5. 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),
6. patients with contraindication to anticoagulation,
7. patients with contraindication to right or left sided heart catheterization,
8. pregnancy,
9. life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
10. patients cannot be removed from antiarrhythmic drugs for reasons other than AF.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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498 participants in 2 patient groups

Upgraded '2C3L'

Experimental group

Description:

Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavotricuspid isthmus (CTI).

Treatment:

Procedure: upgraded '2C3L'

Pulmonary vein antral isolation (PVI)

Active Comparator group

Description:

Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.

Treatment:

Procedure: pulmonary vein antral isolation