Back to results

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

Primary Purpose

Atrial Fibrillation Recurrent

Status

Recruiting

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Atrial fibrillation ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation Recurrent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Atrial fibrillation ablation candidates Exclusion Criteria: Previous catheter ablation Persistent atrial fibrillation

Sites / Locations

Fondazione Policlinico Agostino Gemelli Roma IRCCSRecruiting

Outcomes

Primary Outcome Measures

Atrial fibrillation recurrences

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05781282

First Posted

March 1, 2023

Last Updated

March 23, 2023

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT05781282

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation Recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Atrial fibrillation ablation

Intervention Description

Pulmonary vein deconnection. PV antra visualization by ICE

Primary Outcome Measure Information:

Title

Atrial fibrillation recurrences

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Atrial fibrillation ablation candidates Exclusion Criteria: Previous catheter ablation Persistent atrial fibrillation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gianluigi Bencardino, Dr

Phone

+039 0630154187

gianluigi.bencardino@policlinicogemelli.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gianluigi Bencardino, Dr

Organizational Affiliation

Fondazione Policlinico Agostino Gemelli Roma IRCCS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione Policlinico Agostino Gemelli Roma IRCCS

City

Roma

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gianluigi Bencardino

gianluigi.bencardino@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34554367

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs