Clinical trial NCT04497376: Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Official title: Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Catheter Ablation
Keywords: Pulmonary vein antral isolation
Upgraded '2C3L'
Arrhythmia-free survival
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Heart Health Research Centre
name: The George Institute for Global Health, China
name: The George Institute for Global Health, Australia
name: Fukuoka University
First posted: 2020-08-04
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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).

Eligibility 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.

Primary outcomes:
measure: The recurrence rate of atrial tachycardia arrhythmias
timeFrame: 1 year
Secondary outcomes:
measure: Freedom from AF/AT with or without AADs
timeFrame: 1 year
measure: Freedom from AF/AT off AADs
timeFrame: 1 year
measure: Freedom from AF off AADs
timeFrame: 1 year
measure: AF burden
timeFrame: 1 year
measure: Freedom from AF/AT after multiple procedures
timeFrame: 1 year
measure: Incidence of procedural complications
timeFrame: Within 1 month after the procedure
measure: AFEQT score change between baseline and 12 month
timeFrame: 1 year
measure: EQ5D score change between baseline and 12 month
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Hangzhou
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
state: Jiangsu
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Anzhen Hospital
name: Caihua Sang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University
name: Jianzeng Dong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Chenyang Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: