Expert opinion on design and endpoints for studies on catheter ablation of atrial fibrillation

Thorsten Lewalter^{1

2}, Carina Blomström-Lundqvist^{3

4}, Dhanunjaya Lakkireddy⁵, Douglas Packer⁶, Ralf Meyer⁷, Malte Kuniss⁸, Karl-H Ladwig^{9

10}, Clemens Jilek^{11

12}, Hans-C Diener¹³, Giuseppe Boriani¹⁴, Mintu P Turakhia¹⁵, Steffen Schneider¹⁶, Emma Svennberg¹⁷, Bert Albers¹⁸, Jason G Andrade¹⁹, Mirko de Melis²⁰, Johannes Brachmann²¹

Affiliations

¹ Department of Cardiology and Intensive Unit Care, Hospital Munich South, Peter Osypka Heart Center, Munich, Germany.
² University of Bonn, Bonn, Germany.
³ Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
⁴ Department of Medical Science, Uppsala University, Uppsala, Sweden.
⁵ Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
⁶ Mayo Clinic-St. Mary's Hospital, Rochester, Minnesota, USA.
⁷ Director Clinical Research, Medtronic Cardiac Ablation Solutions, Medtronic GmbH, Meerbusch, Germany.
⁸ Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
⁹ Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
¹⁰ German Center for Cardiovascular Research (DZHK), Partnersite Munich Heart Alliance, Munich, Germany.
¹¹ Department of Cardiology, Peter Osypka Heart Center, Hospital Munich South, Munich, Germany.
¹² Technical University Munich (TUM), Munich, Germany.
¹³ Institute for Medical Informatics, Biometry and Epidemiology, Neurology Emeritus, Medical Faculty of the University Duisburg-Essen, Head Unit of Neuroepidemiology, Essen-Werden, Germany.
¹⁴ Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, Italy University of Modena and Reggio Emilia, Modena University Hospital, Modena, Italy.
¹⁵ Department of Medicine (Cardiovascular Medicine) and Center for Digital Health, Stanford University, Stanford, California, USA.
¹⁶ Stiftung Institut für Herzinfarktforschung - Foundation IHF, Ludwigshafen, Germany.
¹⁷ Department of Medicine Huddinge, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.
¹⁸ Albers Clinical Evidence Consultancy, Winterswijk Woold, The Netherlands.
¹⁹ Vancouver General Hospital, Vancouver, Canada.
²⁰ Medtronic Bakken Research Center, Maastricht, The Netherlands.
²¹ Medical School REGIOMED, REGIOMED-Kliniken Coburg Germany and University of Split School of Medicine, Split, Croatia.

PMID: 39319521
DOI: 10.1111/jce.16443

Practice Guideline

Expert opinion on design and endpoints for studies on catheter ablation of atrial fibrillation

Thorsten Lewalter et al. J Cardiovasc Electrophysiol. 2024 Nov.

. 2024 Nov;35(11):2182-2201.

doi: 10.1111/jce.16443. Epub 2024 Sep 25.

Authors

Affiliations

¹ Department of Cardiology and Intensive Unit Care, Hospital Munich South, Peter Osypka Heart Center, Munich, Germany.
² University of Bonn, Bonn, Germany.
³ Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
⁴ Department of Medical Science, Uppsala University, Uppsala, Sweden.
⁵ Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
⁶ Mayo Clinic-St. Mary's Hospital, Rochester, Minnesota, USA.
⁷ Director Clinical Research, Medtronic Cardiac Ablation Solutions, Medtronic GmbH, Meerbusch, Germany.
⁸ Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
⁹ Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
¹⁰ German Center for Cardiovascular Research (DZHK), Partnersite Munich Heart Alliance, Munich, Germany.
¹¹ Department of Cardiology, Peter Osypka Heart Center, Hospital Munich South, Munich, Germany.
¹² Technical University Munich (TUM), Munich, Germany.
¹³ Institute for Medical Informatics, Biometry and Epidemiology, Neurology Emeritus, Medical Faculty of the University Duisburg-Essen, Head Unit of Neuroepidemiology, Essen-Werden, Germany.
¹⁴ Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, Italy University of Modena and Reggio Emilia, Modena University Hospital, Modena, Italy.
¹⁵ Department of Medicine (Cardiovascular Medicine) and Center for Digital Health, Stanford University, Stanford, California, USA.
¹⁶ Stiftung Institut für Herzinfarktforschung - Foundation IHF, Ludwigshafen, Germany.
¹⁷ Department of Medicine Huddinge, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.
¹⁸ Albers Clinical Evidence Consultancy, Winterswijk Woold, The Netherlands.
¹⁹ Vancouver General Hospital, Vancouver, Canada.
²⁰ Medtronic Bakken Research Center, Maastricht, The Netherlands.
²¹ Medical School REGIOMED, REGIOMED-Kliniken Coburg Germany and University of Split School of Medicine, Split, Croatia.

PMID: 39319521
DOI: 10.1111/jce.16443

Abstract

Introduction: Catheter ablation of atrial fibrillation (AF) is frequently studied in randomized trials, observational and registry studies. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of future clinical studies on catheter ablation of AF, implement lessons learned from previous studies, and promote a higher degree of consistency across studies.

Background: Studies on catheter ablation of AF may benefit from well-described definitions of endpoints and consistent methodology and documentation of outcomes related to efficacy, safety and cost-effectiveness. The availably of new, innovative technologies warrants further consideration about their application and impact on study design and the choice of endpoints. Moreover, recent insights gained from AF ablation studies suggest a reconsideration of some methodological aspects.

Methods: A panel of clinical experts on catheter ablation of AF and designing and conducting clinical studies developed an expert opinion on the design and endpoints for studies on catheter ablation of AF. Discussions within the expert panel with the aim to reach consensus on predefined topics were based on outcomes reported in the literature and experiences from recent clinical trials.

Results: A comprehensive set of recommendations is presented. Key elements include the documentation of clinical AF, medication during the study, repeated ablations and their effect on endpoint assessments, postablation blanking and the choice of rhythm-related and other endpoints.

Conclusion: This expert opinion provides guidance and promotes consistency regarding design of AF catheter ablation studies and identified aspects requiring further research to optimize study design and methodology.

Condensed abstract: Recent insights from studies on catheter ablation of atrial fibrillation (AF) and the availability of new innovative technologies warrant reconsideration of methodological aspects related to study design and the choice and assessment of endpoints. This expert opinion, developed by clinical experts on catheter ablation of AF provides a comprehensive set of recommendations related to these methodological aspects. The aim of this expert opinion is to provide guidance for clinicians and industry regarding the development of clinical studies, implement lessons learned from previous studies, and promote a higher degree of consistency across studies.

Keywords: atrial fibrillation; catheter ablation; clinical studies; endpoints; postablation blanking; study design.

PubMed Disclaimer

References

REFERENCES

1. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275‐e444.
1. Food and Drug Administration. Clinical Trials Guidance Documents. 2023. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...
1. European Medicines Agency. Guideline for good clinical practice E6(R2) Step 5. 2016. European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guidelin...
1. International Organization for Standardization. ISO 14155:2020 Clinical investigation of medical devices for human subjects ‐ Good clinical practice. 2020. International Organization for Standardization. https://www.iso.org/standard/71690.html
1. Packer DL, Mark DB, Robb RA, et al. Effect of catheter ablation vs antiarrhythmic drug therapy on mortality, stroke, bleeding, and cardiac arrest among patients with atrial fibrillation: the CABANA randomized clinical trial. JAMA. 2019;321(13):1261‐1274.

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Grants and funding

Cardiovascular Academy gGmbH, Munich, Germany

LinkOut - more resources

Full Text Sources
- Ovid Technologies, Inc.
- Wiley
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Expert opinion on design and endpoints for studies on catheter ablation of atrial fibrillation

Affiliations

Expert opinion on design and endpoints for studies on catheter ablation of atrial fibrillation

Authors

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical