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

Phase 4

Recruiting

• Conditions: Atrial Fibrillation Recurrent

• Registration Number: NCT05781282
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-11
• Study First Posted: 2023-03-23
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-01-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Atrial fibrillation ablation candidates

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Exclusion Criteria

• Previous catheter ablation
• Persistent atrial fibrillation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation recurrences	12 months	Recurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli Roma IRCCS; 🇮🇹 Roma, Italy