Prospective randomized comparison between upgraded ‘2C3L’ vs. PVI approach for catheter ablation of persistent atrial fibrillation: PROMPT-AF trial design - 03/05/23

Doi : 10.1016/j.ahj.2023.01.019

Xiao-Xia Liu, MD ^a, Qiang Liu, MD ^b, Yi-Wei Lai, MD ^a, Qi Guo, MD ^a, Rong Bai, MD ^a,^c, De-Yong Long, MD ^a, Rong-Hui Yu, MD ^a, Ri-Bo Tang, MD ^a, Nian Liu, MD ^a, Chen-Xi Jiang, MD ^a, Wei Wang, MD ^a, Xue-Yuan Guo, MD ^a, Song-Nan Li, MD ^a, Xin Zhao, MD ^a, Song Zuo, MD ^a, Chang-Yi Li, MD ^a, Shang-Ming Song, MD ^d, Shuang-Lun Xie, MD ^e, Wei-Li Ge, MD ^f, Jian-Gang Zou, MD ^g, Xiao-Feng Hou, MD ^g, Ke Chen, MD ^h, Jin-Lin Zhang, MD ⁱ, He-Sheng Hu, MD ^j, Xin-Hua Wang, MD ^k, Zhao-Jun Wang, MD ^l, Xin Du, MD ^a,^m,^n,^o, Chen-Yang Jiang, MD ^b,^⁎ , Cai-Hua Sang, MD ^a,^⁎ , Jian-Zeng Dong, MD ^a,^p, Chang-Sheng Ma, MD ^a
^a Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
^b Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China
^c Banner University Medical Center-Phoenix, The University of Arizona College of Medicine, Phoenix AZ, USA
^d Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China
^e China Department of Cardiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
^f Department of Cardiology, Taizhou Hospital of Zhejiang Province, Taizhou, China
^g Department of Cardiology, Jiangsu Province Hospital, Nanjing, China
^h Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
ⁱ Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
^j Department of Cardiology, the First Affiliated Hospital of Shandong First Medical University, Jinan, China
^k Department of Cardiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
^l Department of Cardiology, the First Affiliated Hospital of Harbin Medical University, Harbin, China
^m National Clinical Research Center for Cardiovascular Diseases, Beijing Advanced Innovation Center for Big Data-Based Precision Medicine for Cardiovascular Diseases, Beijing, China
ⁿ Heart Health Research Center, Beijing, China
^o The George Institute for Global Health, The University of New South Wales, Sydney, Australia
^p Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

^⁎Reprint requests: Cai-Hua Sang, MD, Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Chaoyang District, Beijing, PR China, Zip 100029, Telephone: 86-010-64456078Department of CardiologyBeijing Anzhen HospitalCapital Medical UniversityChaoyang DistrictBeijing100029PR China^⁎⁎Reprint requests: Chen-Yang Jiang, MD, Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Shangcheng District, Zhejiang, PR China, Zip 310016, Telephone: 86-13857190051Department of CardiologySir Run Run Shaw HospitalSchool of MedicineZhejiang UniversityShangcheng DistrictZhejiang310016PR China

Riassunto

Background

In randomized studies, the strategy of pulmonary vein antral isolation (PVI) plus linear ablation has failed to increase success rates for persistent atrial fibrillation (PeAF) ablation when compared with PVI alone. Peri-mitral reentry related atrial tachycardia due to incomplete linear block is an important cause of clinical failures of a first ablation procedure. Ethanol infusion (EI) into the vein of Marshall (EI-VOM) has been demonstrated to facilitate a durable mitral isthmus linear lesion.

Objective

This trial is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded ‘2C3L’ for the ablation of PeAF.

Study Design

The PROMPT-AF study (clinicaltrials.gov 04497376) is a prospective, multicenter, open-label, randomized trial using a 1:1 parallel-control approach. Patients (n = 498) undergoing their first catheter ablation of PeAF 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 3 linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary end point is freedom from atrial arrhythmias of >30 seconds, without antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).

Conclusions

The PROMPT-AF study will evaluate the efficacy of the fixed ‘2C3L’ approach in conjunction with EI-VOM, compared with PVI alone, in patients with PeAF undergoing de novo ablation.

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Common pathways of the procedure

PVI procedure

Upgraded ‘2C3L’ approach procedure

Peri-ablation anticoagulation

Use of antiarrhythmic drugs

Statistical considerations

Summary

Funding

Esportazione

Vol 260

P. 34-43 - giugno 2023 Ritorno al numero

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Prospective randomized comparison between upgraded ‘2C3L’ vs. PVI approach for catheter ablation of persistent atrial fibrillation: PROMPT-AF trial design - 03/05/23

Riassunto

Background

Objective

Study Design

Conclusions

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