NCT07435181

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Accessory pathwayRadiofrequency ablationWolff-Parkinson-White

Outcome Measures

Primary Outcomes (1)

  • Acute procedural success

    At the end of the index procedure

Secondary Outcomes (2)

  • Procedural complexity

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

  • Durability of successful radiofrequency ablation

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

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Santinelli V, Radinovic A, Manguso F, et al. The natural history of asymptomatic ventricular pre-excitation a long-term prospective follow-up study of 184 asymptomatic children. J Am Coll Cardiol. 2009;53(3):275-280. doi:10.1016/j.jacc.2008.09.037

    BACKGROUND
  • Pappone C, Santinelli V, Rosanio S, et al. 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;41(2):239-244. doi:10.1016/s0735- 1097(02)02706-7

    BACKGROUND
  • Jackman WM, Wang XZ, Friday KJ, et al. Catheter ablation of accessory atrioventricular pathways (Wolff- Parkinson-White syndrome) by radiofrequency current. N Engl J Med. 1991;324(23):1605-1611. doi:10.1056/NEJM199106063242301

    BACKGROUND

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal ReentryWolff-Parkinson-White SyndromeSyndromePre-Excitation Syndromes

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingTachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease

Central Study Contacts

Simone Gulletta, MD

CONTACT

Marcello Cosenza, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share