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Prospective randomized comparison between upgraded '2C3L' vs. PVI approach for catheter ablation of persistent atrial fibrillation: PROMPT-AF trial design.

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Author information

Affiliations

  • 1. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
      Authors
    • Liu XX 1
    • Lai YW 1
    • Guo Q 1
    • Long DY 1
    • Yu RH 1
    • Tang RB 1
    • Liu N 1
    • Jiang CX 1
    • Wang W 1
    • Guo XY 1
    • Li SN 1
    • Zhao X 1
    • Zuo S 1
    • Li CY 1
    • Sang CH 1
    • Ma CS 1
    (16 authors)
  • 2. Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
      Authors
    • Liu Q 2
    • Jiang CY 2
    (2 authors)
  • 3. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Banner University Medical Center-Phoenix, The University of Arizona College of Medicine, Phoenix AZ, USA.
      Authors
    • Bai R 3
    (1 author)
  • 4. Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
      Authors
    • Song SM 4
    (1 author)
  • 5. China Department of Cardiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
      Authors
    • Xie SL 5
    (1 author)
    • Show all (14)

ORCIDs linked to this article

American Heart Journal, 20 Feb 2023, 260:34-43
https://doi.org/10.1016/j.ahj.2023.01.019 PMID: 36813122 

Abstract 

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.

Full text links 

Read article at publisher's site: https://doi.org/10.1016/j.ahj.2023.01.019

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