A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives

Abstract

Purpose: Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes.

Methods: Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable.

Results: Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients.

Discussion: Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019).

Keywords: Atrial fibrillation; Catheter ablation; Outcomes; Registry.

Conflict of interest statement

Brigham Godfrey reports honoraria and consulting from Biosense Webster. Benjamin D’Souza reports honoraria and consulting from Biosense Webster, Abbott, and Stereotaxis. Steven Kang reports honoraria and consulting from Biosense Webster and Boston Scientific. Brett Gidney reports Consulting and Speaking for Biosense Webster, Nuvera, Boston Scientific, Atricure, Abbott, Janssen, and Siemens. Tariq Salam reports consulting from Biosense Webster. Mark D. Metzl reports honoraria and consulting from Abbot, Biosense Webster, and Medtronic. Alexandru Costea reports honoraria and consulting from Biosense Webster and BIOTRONIK. Saumil Oza reports honoraria and consulting from Biosense Webster. Gustavo Morales reports research support, consulting, and honoraria from Biosense Webster. Anil Rajendra reports honoraria and consulting from Biosense Webster, Philips, and Acutus Medical. Joshua Silverstein reports honoraria and consulting from Biosense Webster and Medtronic. Paul C. Zei reports research support and consulting from Biosense Webster; consulting and honoraria from Abbot; research support and consulting from Varian, Boehringer Ingelheim (expert witness); and consulting from Affera. Jose Osorio serves as a consultant for and has received honoraria and research grants from Biosense Webster and Boston Scientific. The rest of the authors have no conflicts of interest or disclosures.

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