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

NCT ID: NCT04497376

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 498 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2024-07-18

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).

Conditions

Persistent Atrial Fibrillation; Catheter Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Upgraded '2C3L'

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).

Group Type: EXPERIMENTAL

upgraded '2C3L'

Intervention Type: 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.

Pulmonary vein antral isolation (PVI)

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.

Group Type: ACTIVE_COMPARATOR

pulmonary vein antral isolation

Intervention Type: 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.

Interventions

upgraded '2C3L'

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.

Intervention Type: PROCEDURE

pulmonary vein antral isolation

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.

Intervention Type: PROCEDURE

Other Intervention Names

EI-VOM+2C3L; PVI

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Health Research Centre

UNKNOWN

Sponsor Role: collaborator

The George Institute for Global Health, China

OTHER

Sponsor Role: collaborator

The George Institute for Global Health, Australia

OTHER

Sponsor Role: collaborator

Fukuoka University

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang sheng Ma

Director of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caihua Sang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Changsheng Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Jianzeng Dong, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University

Chenyang Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Taizhou Hospital of Zhejiang Province

Taizhou, Hangzhou, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

Shengli Oilfield Central Hospital

Dongying, Shandong, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Shanghai Renji Hospital

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39556379 (View on PubMed)

Other Identifiers

2017YFC0908803

Identifier Type: -

Identifier Source: org_study_id