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Status unknownNCT05781282Updated Mar 27, 2023

Pulmonary Vein (PV) Imaging by Intracardiac Echography (ICE) After Ablation

A Phase 4 interventional study of Atrial fibrillation ablation in Atrial Fibrillation Recurrent, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2021, registered Mar 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences

Read the detailed description

Patient undergoing first RF ablation for sympomatic paroxysmal atrial fibrillation will be enrolled. ICE visualization of PV antra before and after PV deconnection (electrophysiological endpoint). Changes in echogenicity as documented by ICE will be evaluated by a dedicated software and correlated to long term recurrences

02

Conditions studied

  • Atrial Fibrillation Recurrent

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 18 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Atrial fibrillation ablation candidates

Exclusion criteria

Exclusion Criteria:

  • Previous catheter ablation
  • Persistent atrial fibrillation
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
18 participants (estimated)

Interventions

  • DeviceAtrial fibrillation ablation

    Pulmonary vein deconnection. PV antra visualization by ICE

06

What researchers measure

Primary outcomes

  1. Atrial fibrillation recurrences

    Recurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Leo M, De Maria GL, Briosa E Gala A, Pope M, Banerjee A, Kelion A, Pedersen M, Rajappan K, Ginks M, Bashir Y, Hunter RJ, Betts T. INtra-procedural ultraSound Imaging for DEtermination of atrial wall thickness and acute tissue changes after isolation of the pulmonary veins with radiofrequency, cryoballoon or laser balloon energy: the INSIDE PVs study. Int J Cardiovasc Imaging. 2021 Dec;37(12):3525-3535. doi: 10.1007/s10554-021-02417-7. Epub 2021 Sep 23. PubMed 34554367 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05781282
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Bencardino Gianluigi (Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 23, 2023
Start date
Nov 1, 2021
Primary completion
Jan 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Mar 27, 2023

Study contacts

Gianluigi Bencardino, Dr
Contact
gianluigi.bencardino@policlinicogemelli.it
+039 0630154187
Gianluigi Bencardino, Dr
principal investigator · Fondazione Policlinico Agostino Gemelli Roma IRCCS

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 status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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