Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation

NCT04497376 | Completed DMC

• 1 other identifier: 2017YFC0908803
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 12

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.

Conditions

Persistent Atrial Fibrillation; Catheter Ablation

Keywords

Pulmonary vein antral isolation; Upgraded '2C3L'; Arrhythmia-free survival

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of atrial tachycardia arrhythmias

  freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.

  1 year

Secondary Outcomes (8)

• Freedom from AF/AT with or without AADs

  1 year

• Freedom from AF/AT off AADs

  1 year

• Freedom from AF off AADs

  1 year

• AF burden

  1 year

• Freedom from AF/AT after multiple procedures

  1 year

Study Arms (2)

Upgraded '2C3L'

EXPERIMENTAL

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).

Procedure: upgraded '2C3L'

Pulmonary vein antral isolation (PVI)

ACTIVE COMPARATOR

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.

Procedure: pulmonary vein antral isolation

Interventions

upgraded '2C3L' PROCEDURE

Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.

Also known as: EI-VOM+2C3L

Upgraded '2C3L'

pulmonary vein antral isolation PROCEDURE

After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) 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. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.

Also known as: PVI

Pulmonary vein antral isolation (PVI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Heart Health Research Centre: collaborator
• The George Institute for Global Health, China: collaborator
• The George Institute for Global Health, Australia: collaborator
• Fukuoka University: collaborator

Study Sites (12)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510235, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Hangzhou, 318050, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 451464, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

Location

Shengli Oilfield Central Hospital

Dongying, Shandong, 257034, China

Location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250013, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Shanghai Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (1)

• Sang C, Liu Q, Lai Y, Xia S, Jiang R, Li S, Guo Q, Li Q, Gao M, Guo X, Huang L, Liu N, Jiang C, Zuo S, Liu X, Li M, Ge W, Song S, Chen L, Xie S, Zou J, Chen K, Liu X, Hu H, Wang X, Zhang J, Wang Z, Wang C, He L, Jiang C, Tang R, Zhou N, Wang Y, Long D, Du X, Jiang C, Macle L, Dong J, Ma C; PROMPT-AF investigators. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):381-389. doi: 10.1001/jama.2024.24438.

  PMID: 39556379 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caihua Sang, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Changsheng Ma, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Jianzeng Dong, MD

  Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Chenyang Jiang, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: August 4, 2020
• Study Start: August 27, 2021
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

CN (12)