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Peer-reviewedCC BY 4.0Journal of Clinical Medicine

Repeat Ablation for Persistent Atrial Fibrillation: CFA/DOA-Guided Substrate Ablation Versus Re-PVI Alone in the Prematurely Terminated Randomized AF-CAM Trial

3 more authors
6 affiliations
  1. 1Department of Cardiology and Intensive Care Medicine, Faculty of Medicine, Semmelweis University Campus Hamburg, Asklepios Hospital St. Georg, 20099 Hamburg, Germany
  2. 2Atrial Fibrillation Network (AFNET), 48149 Münster, Germany
  3. 3Asklepios Proresearch, Research Institute, 20099 Hamburg, Germany
  4. 4Evangelical Hospital Duesseldorf, 40217 Duesseldorf, Germany
  5. 5Heart Center, Cologne University Hospital, 50937 Cologne, Germany
  6. 6Medical School Hamburg, 20457 Hamburg, Germany

Abstract

Background and Aims: Currently, no standard approach exists for substrate ablation in persistent atrial fibrillation (AF). This study aimed to assess whether repeat pulmonary vein isolation (Re-PVI) plus targeted substrate ablation improves long-term outcomes compared with Re-PVI alone in patients with persistent AF undergoing a second ablation. Methods: The AF-CAM study is an investigator-initiated, prospective, randomized, open-label, blinded-endpoint, multi-center clinical trial. Patients with persistent AF undergoing a second ablation for arrhythmia recurrence were randomized 1:1 to either Group A (Re-PVI alone) or Group B (Re-PVI plus targeted ablation). The primary endpoint was freedom from any atrial arrhythmia (>30 s) between 3 and 12 months of follow-up. Results: Between August 2021 and November 2023, 56 patients (mean age 68 ± 10 years, 32% women) were randomized before the trial was terminated prematurely. There was no evidence of a difference in arrhythmia recurrence between the treatment groups (hazard ratio [HR] for recurrence, Group B vs. Group A: 1.07; 95% confidence interval [CI] 0.50 to 2.33; p = 0.85). Pulmonary vein reconnection was present in 86% of patients and was not associated with the risk of atrial arrhythmia recurrence (HR 0.927, 95% CI [0.275, 3.120]). Across both groups, catheter ablation was associated with improvements in quality of life (AFEQT score) and reductions in BNP levels during follow-up. Conclusions: In this prematurely terminated randomized trial, adding CFA- and DOA-guided substrate ablation to Re-PVI did not demonstrate an improvement in freedom from atrial arrhythmia compared with Re-PVI alone. The small sample size and imprecise treatment estimate preclude a definitive conclusion about the efficacy of the adjunctive strategy. AFEQT scores increased and BNP levels decreased over follow-up in the studied patients. Larger studies are needed to further evaluate the complex atrial substrate in persistent AF.

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BibTeX
@article{willems2026repeat,
  title = {{Repeat Ablation for Persistent Atrial Fibrillation: CFA/DOA-Guided Substrate Ablation Versus Re-PVI Alone in the Prematurely Terminated Randomized AF-CAM Trial}},
  author = {Stephan Willems and Pawel Kuklik and Peter Wohlmuth and Melanie A. Gunawardene and Jens Hartmann and Jannis Dickow and Tim Harloff and Kathrin Heitmann and Christian Meyer and Katharina Scherschel and Susanne Scholz and Arian Sultan and Rahin Wahedi and Arso Zahir-Akkra and Nele Gessler},
  journal = {Journal of Clinical Medicine},
  year = {2026},
  month = oct,
  doi = {10.3390/jcm15208010},
  url = {https://www.mdpi.com/2077-0383/15/20/8010},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Repeat Ablation for Persistent Atrial Fibrillation: CFA/DOA-Guided Substrate Ablation Versus Re-PVI Alone in the Prematurely Terminated Randomized AF-CAM Trial
AU  - Stephan Willems
AU  - Pawel Kuklik
AU  - Peter Wohlmuth
AU  - Melanie A. Gunawardene
AU  - Jens Hartmann
AU  - Jannis Dickow
AU  - Tim Harloff
AU  - Kathrin Heitmann
AU  - Christian Meyer
AU  - Katharina Scherschel
AU  - Susanne Scholz
AU  - Arian Sultan
AU  - Rahin Wahedi
AU  - Arso Zahir-Akkra
AU  - Nele Gessler
PY  - 2026
DA  - 2026/10/01
JO  - Journal of Clinical Medicine
DO  - 10.3390/jcm15208010
UR  - https://www.mdpi.com/2077-0383/15/20/8010
AB  - Background and Aims: Currently, no standard approach exists for substrate ablation in persistent atrial fibrillation (AF). This study aimed to assess whether repeat pulmonary vein isolation (Re-PVI) plus targeted substrate ablation improves long-term outcomes compared with Re-PVI alone in patients with persistent AF undergoing a second ablation. Methods: The AF-CAM study is an investigator-initiated, prospective, randomized, open-label, blinded-endpoint, multi-center clinical trial. Patients with persistent AF undergoing a second ablation for arrhythmia recurrence were randomized 1:1 to either Group A (Re-PVI alone) or Group B (Re-PVI plus targeted ablation). The primary endpoint was freedom from any atrial arrhythmia (>30 s) between 3 and 12 months of follow-up. Results: Between August 2021 and November 2023, 56 patients (mean age 68 ± 10 years, 32% women) were randomized before the trial was terminated prematurely. There was no evidence of a difference in arrhythmia recurrence between the treatment groups (hazard ratio [HR] for recurrence, Group B vs. Group A: 1.07; 95% confidence interval [CI] 0.50 to 2.33; p = 0.85). Pulmonary vein reconnection was present in 86% of patients and was not associated with the risk of atrial arrhythmia recurrence (HR 0.927, 95% CI [0.275, 3.120]). Across both groups, catheter ablation was associated with improvements in quality of life (AFEQT score) and reductions in BNP levels during follow-up. Conclusions: In this prematurely terminated randomized trial, adding CFA- and DOA-guided substrate ablation to Re-PVI did not demonstrate an improvement in freedom from atrial arrhythmia compared with Re-PVI alone. The small sample size and imprecise treatment estimate preclude a definitive conclusion about the efficacy of the adjunctive strategy. AFEQT scores increased and BNP levels decreased over follow-up in the studied patients. Larger studies are needed to further evaluate the complex atrial substrate in persistent AF.
SN  - 2077-0383
ER  -