ClinicalTrials.gg
Not yet recruitingNCT07435181Updated Feb 27, 2026

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

An observational study in Atrioventricular Reentrant Tachycardias and Wolff-Parkinson-White (WPW) Syndrome, sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by IRCCS Ospedale San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
220
Ages
5 Years to 60 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Atrioventricular Reentrant Tachycardias
  • Wolff-Parkinson-White (WPW) Syndrome

Keywords

  • Accessory pathway
  • Radiofrequency ablation
  • Wolff-Parkinson-White
03

In context

Tachycardia, Atrioventricular Nodal Reentry

23 studies on the registry are indexed under Tachycardia, Atrioventricular Nodal Reentry; 5 are open to participants now.

Browse Tachycardia, Atrioventricular Nodal Reentry studies →

Lead sponsor

IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who consecutively underwent an electrophysiological (EP) study at San Raffaele Scientific Institute for EP study due to paroxysmal SVT with documented acessory pathway

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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 , 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 period of the AP, rapid conduction during atrial fibrillation), or Induction of sustained AVRT during the EP study.

  2. Aged between 5 to 60 years old

Exclusion criteria

Exclusion Criteria:

  1. Lack of pre-specified follow-up: only patients with at least 1 years follow-up ambulatory visit will be included in the study
  2. REDO CA procedure
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
220 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Acute procedural success

    Time frame: At the end of the index procedure

Secondary outcomes

  1. Procedural complexity

    Time frame: From the end of the index procedure to discharge and at the ambulatory follow-up visits

  2. Durability of successful radiofrequency ablation

    Time frame: From the end of the index procedure to discharge and at the ambulatory follow-up visits

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 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: 10.1016/s0735-1097(02)02706-7. PubMed 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. PubMed 2030716 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07435181
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Marcello Cosenza (MD, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Feb 27, 2026
Start date
Apr 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Simone Gulletta, MD
Contact
gulletta.simone@hsr.it
02 2643 7484
Marcello Cosenza, MD
Contact
cosenza.marcello@hsr.it
02 2643 689

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion