Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial FibrillationCatheter Ablation
- Interventions
- Procedure: upgraded '2C3L'Procedure: pulmonary vein antral isolation
- Registration Number
- NCT04497376
- Lead Sponsor
- Beijing Anzhen Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 498
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Upgraded '2C3L' 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). Pulmonary vein antral isolation (PVI) pulmonary vein antral isolation 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.
- Primary Outcome Measures
Name Time Method The recurrence rate of atrial tachycardia arrhythmias 1 year 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.
- Secondary Outcome Measures
Name Time Method Freedom from AF/AT off AADs 1 year Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
Freedom from AF/AT with or without AADs 1 year Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.
AFEQT score change between baseline and 12 month 1 year Quality of life assessed by AF effect on quality-of-life (AFEQT) questionaire
Freedom from AF off AADs 1 year Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
AF burden 1 year AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period,
Freedom from AF/AT after multiple procedures 1 year freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.
EQ5D score change between baseline and 12 month 1 year Quality of life assessed by EuroQol 5-dimension (EQ5D) scale
Incidence of procedural complications Within 1 month after the procedure cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, leading to death, intervention required, or prolonged hospitalization, strokes /thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
Trial Locations
- Locations (12)
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Shengli Oilfield Central Hospital
🇨🇳Dongying, Shandong, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
Jiangsu Provincial Hospital
🇨🇳Nanjing, Jiangsu, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shanghai Renji Hospital
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, 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
Beijing Anzhen Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China