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Not yet recruiting NCT07435181

Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study

— Observational Atrioventricular Reentrant Tachycardias Wolff-Parkinson-White (WPW) Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome. Basic parameters: 5 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The aim of this observational, retrospective study is to evaluate, comparatively, procedural outcomes of APs (Accessory pathway) ablation according to the conduction properties (i.e., manifest vs. concealed) and to assess both short- and long-term outcomes of RFA (RF ablation).

Primary outcome measures

  • Acute procedural success [Time frame: At the end of the index procedure]
Secondary outcome measures (2)
  • Procedural complexity [Time frame: From the end of the index procedure to discharge and at the ambulatory follow-up visits]
  • Durability of successful radiofrequency ablation [Time frame: From the end of the index procedure to discharge and at the ambulatory follow-up visits]

Eligibility criteria

Inclusion criteria

  • Patients who consecutively underwent an electrophysiological (EP) study between 2005 and 2023 at San Raffaele Scientific Institute are included if they met one of the following criteria:

Patients referred for EP study due to:

  • EITHER clinical suspicion of paroxysmal supraventricular tachycardia without prior documentation of ventricular pre-excitation and/or supraventricular arrhythmia (SVA) on 12-lead surface electrocardiogram, OR with electrocardiographic evidence of SVA, AND electrophysiological confirmation of atrioventricular re-entrant tachycardia (AVRT) as the arrhythmic mechanism.
  • Ventricular pre-excitation documented on serial 12-lead surface ECGs, with or without clinical episodes suggestive of AVRT, who underwent catheter ablation of the accessory pathway based on:

The presence of high-risk electrophysiological features (e.g., short antegrade effective refractory period of the AP, rapid conduction during atrial fibrillation), or Induction of sustained AVRT during the EP study.

  • Aged between 5 to 60 years old

Exclusion criteria

  • Lack of pre-specified follow-up: only patients with at least 1 years follow-up ambulatory visit will be included in the study
  • REDO CA procedure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Santinelli V, Radinovic A, Manguso F, Vicedomini G, Gulletta S, Paglino G, Mazzone P, Ciconte G, Sacchi S, Sala S, Pappone C. The natural history of asymptomatic ventricular pre-excitation a long-term prospective follow-up study of 184 asymptomatic children. J Am Coll Cardiol. 2009 Jan 20;53(3):275-80. doi: 10.1016/j.jacc.2008.09.037. PMID 19147045
  • Pappone C, Santinelli V, Rosanio S, Vicedomini G, Nardi S, Pappone A, Tortoriello V, Manguso F, Mazzone P, Gulletta S, Oreto G, Alfieri O. Usefulness of invasive electrophysiologic testing to stratify the risk of arrhythmic events in asymptomatic patients with Wolff-Parkinson-White pattern: results from a large prospective long-term follow-up study. J Am Coll Cardiol. 2003 Jan 15;41(2):239-44. doi PMID 12535816
  • Jackman WM, Wang XZ, Friday KJ, Roman CA, Moulton KP, Beckman KJ, McClelland JH, Twidale N, Hazlitt HA, Prior MI, et al. Catheter ablation of accessory atrioventricular pathways (Wolff-Parkinson-White syndrome) by radiofrequency current. N Engl J Med. 1991 Jun 6;324(23):1605-11. doi: 10.1056/NEJM199106063242301. PMID 2030716

Identifiers

NCT: NCT07435181 · AP-STUDY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗