Atrioventricular Reentrant TachycardiasNCT07435181
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
An observational study of Atrioventricular Reentrant Tachycardias and Wolff-Parkinson-White (WPW) Syndrome, run by IRCCS Ospedale San Raffaele.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
- Keywords
- Accessory pathway, Radiofrequency ablation, Wolff-Parkinson-White
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry, Wolff-Parkinson-White Syndrome, Syndrome, Pre-Excitation Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute procedural success
Measured: At the end of the index procedure
Secondary outcomes (2)
Procedural complexity
Measured: From the end of the index procedure to discharge and at the ambulatory follow-up visits
Durability of successful radiofrequency ablation
Measured: From the end of the index procedure to discharge and at the ambulatory follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular Reentrant TachycardiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Cosenza, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435181
- Sponsor's protocol ID
- AP-STUDY
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19147045Pappone 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 12535816Jackman 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07435181
- Acronym / sponsor ID
- AP-STUDY
- Keywords
- Accessory pathway, Radiofrequency ablation, Wolff-Parkinson-White
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute procedural success
Time frame: At the end of the index procedure
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 19147045Santinelli 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.
- Background: PubMed 12535816Pappone 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.
- Background: PubMed 2030716Jackman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrioventricular Reentrant Tachycardias and Wolff-Parkinson-White (WPW) Syndrome, run by IRCCS Ospedale San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Gulletta, MD (02 2643 7484, gulletta.simone@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute procedural success (time frame: At the end of the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07435181, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.