NCT05781282

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

March 1, 2023

Last Update Submit

March 23, 2023

Conditions

Atrial Fibrillation Recurrent

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrences

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

    12 months

Interventions

Atrial fibrillation ablationDEVICE

Pulmonary vein deconnection. PV antra visualization by ICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atrial fibrillation ablation candidates

You may not qualify if:

  • Previous catheter ablation
  • Persistent atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Agostino Gemelli Roma IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34554367RESULT

Study Officials

  • Gianluigi Bencardino, Dr

    Fondazione Policlinico Agostino Gemelli Roma IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluigi Bencardino, Dr

CONTACT

+039 0630154187gianluigi.bencardino@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 23, 2023

Study Start

November 1, 2021

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

IT(1)