Pulmonary Vein (PV) Imaging by Intracardiac Echography (ICE) After Ablation
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05781282
Collaborator
(none)
18
1
31
0.6
Study Details
Study Description
Brief Summary
To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Pulmonary Vein Imaging by ICE After Atrial Fibrillation Ablation to Predict Recurrences
Actual Study Start Date
:
Nov 1, 2021
Anticipated Primary Completion Date
:
Jan 1, 2024
Anticipated Study Completion Date
:
Jun 1, 2024
Outcome Measures
Primary Outcome Measures
- Atrial fibrillation recurrences [12 months]
Recurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Atrial fibrillation ablation candidates
Exclusion Criteria:
-
Previous catheter ablation
-
Persistent atrial fibrillation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Agostino Gemelli Roma IRCCS | Roma | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Gianluigi Bencardino, Dr, Fondazione Policlinico Agostino Gemelli Roma IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bencardino Gianluigi,
Principal Investigator,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05781282
Other Study ID Numbers:
- 3747
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: