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

Pulmonary Vein Imaging by ICE After Atrial Fibrillation Ablation to Predict Recurrences

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05781282
Enrollment
18
Registered
2023-03-23
Start date
2021-11-01
Completion date
2024-06-01
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Recurrent

Brief summary

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

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

Interventions

DEVICEAtrial fibrillation ablation

Pulmonary vein deconnection. PV antra visualization by ICE

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Atrial fibrillation ablation candidates

Exclusion criteria

* Previous catheter ablation * Persistent atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
Atrial fibrillation recurrences12 monthsRecurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection

Countries

Italy

Contacts

Primary ContactGianluigi Bencardino, Dr
gianluigi.bencardino@policlinicogemelli.it+039 0630154187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026