Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design.
| Title: | Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design. |
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| Authors: | Bortone AA; Service de Cardiologie, Hôpital Privé Les Franciscaines, ELSAN, Nîmes, France.; Marijon E; Service de Cardiologie, Hôpital Européen Georges Pompidou, Paris, France.; Limite LR; Service de Cardiologie, Hôpital Privé Les Franciscaines, ELSAN, Nîmes, France.; Lagrange P; Service de Cardiologie, Clinique St Pierre, ELSAN, Perpignan, France.; Brigadeau F; Service de Rythmologie, Centre Hospitalo-Universitaire de Lille, Lille, France.; Martins R; Service de Cardiologie, Centre Hospitalo-Universitaire de Rennes, Rennes, France.; Durand C; Service de Rythmologie, Infirmerie Protestante de Lyon, Lyon, France.; Albenque JP; Département de Rythmologie, Clinique Pasteur, Toulouse, France. |
| Corporate Authors: | PACIFIC study group |
| Source: | Journal of cardiovascular electrophysiology [J Cardiovasc Electrophysiol] 2023 Feb; Vol. 34 (2), pp. 270-278. Date of Electronic Publication: 2022 Dec 07. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol |
| Language: | English |
| Journal Info: | Publisher: Blackwell Country of Publication: United States NLM ID: 9010756 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1540-8167 (Electronic) Linking ISSN: 10453873 NLM ISO Abbreviation: J Cardiovasc Electrophysiol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Malden, MA : Blackwell; Original Publication: Mt. Kisco, N.Y. : Futura Pub., c1990- |
| MeSH Terms: | Atrial Fibrillation*/diagnosis ; Atrial Fibrillation*/surgery ; Pulmonary Veins*/surgery ; Catheter Ablation*/adverse effects ; Catheter Ablation*/methods; Electric Countershock/adverse effects ; Humans ; Treatment Outcome ; Recurrence ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic |
| Abstract: | Introduction: Pulmonary vein isolation (PVI) is effective at treating 50% of unselected patients with persistent atrial fibrillation (AF). Alternatively, PVI combined with a new ablation strategy entitled the Marshall-PLAN ensures a 78% 1-year sinus rhythm (SR) maintenance rate in the same population. However, a substantial subset of patients could undergo the Marshall-PLAN unnecessarily. It is therefore essential to identify those patients who can be treated with PVI alone versus those who may truly benefit from the Marshall-PLAN before ablation is performed. In this context, we hypothesized that electrical cardioversion (EC) could help to select the most appropriate strategy for each patient.; Methods: In this multicentre, prospective, randomized study, patients with AF recurrence within 4 weeks after EC will be randomized 1:1 to PVI alone or the Marshall-PLAN. Conversely, patients in whom SR is maintained for ≥4 weeks after EC will be treated with PVI only and included in a prospective registry. The primary endpoint will be the 1-year SR maintenance rate after a single ablation procedure.; Results and Conclusion: The Marshall-PLAN might be necessary in patients with an advanced degree of persistent AF (i.e., where SR is not maintained for ≥4 uninterrupted weeks after EC). Conversely, in patients with mild or moderate persistent AF (i.e., where SR is maintained for ≥4 weeks after EC), PVI alone might be a sufficient ablation strategy. The PACIFIC trial is the first study designed to assess whether rhythm monitoring after EC could help to identify patients who should undergo adjunctive ablation strategies beyond PVI.; (© 2022 Wiley Periodicals LLC.) |
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| Contributed Indexing: | Keywords: Marshall-PLAN; atrial fibrillation; comparative study; electrical cardioversion; pulmonary vein isolation; randomized study |
| Molecular Sequence: | ClinicalTrials.gov NCT05264831 |
| Entry Date(s): | Date Created: 20221126 Date Completed: 20230210 Latest Revision: 20260105 |
| Update Code: | 20260130 |
| DOI: | 10.1111/jce.15761 |
| PMID: | 36434797 |
| Database: | MEDLINE |
Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol