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

NCT ID: NCT05781282

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-06-01

Brief Summary

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

Detailed Description

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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

Conditions

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Atrial Fibrillation Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Atrial fibrillation ablation

Pulmonary vein deconnection. PV antra visualization by ICE

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Atrial fibrillation ablation candidates

Exclusion Criteria

* Previous catheter ablation
* Persistent atrial fibrillation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Bencardino Gianluigi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluigi Bencardino, Dr

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Agostino Gemelli Roma IRCCS

Locations

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Fondazione Policlinico Agostino Gemelli Roma IRCCS

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gianluigi Bencardino, Dr

Role: CONTACT

+039 0630154187

Facility Contacts

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Gianluigi Bencardino

Role: primary

References

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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.

Reference Type RESULT
PMID: 34554367 (View on PubMed)

Other Identifiers

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3747

Identifier Type: -

Identifier Source: org_study_id

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