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Transseptal Italian Registry (TITLE)

Sponsor
Luigi Sacco University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05636046
Collaborator
(none)
1,000
Enrollment
10
Locations
19
Anticipated Duration (Months)
100
Patients Per Site
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about the changing over the time of transseptal (TSP) catheterization for catheter ablation of arrhythmias in the left heart. This study aims to investigate if auxiliary tools for TSP catheterization improved the safety and efficacy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transseptal catheterization

Detailed Description

Data regarding transseptal catheterization in the Centers involved will be retrospectively collected over the past 10 years.

Will be collected:
  1. patients characteristics

  1. type of procedure requiring transseptal catheterization

  2. success rate

  3. adverse events

  4. use of tools for transseptal catheterization:

  • intracardiac echocardiography (ICE) guidance

  • simplified transseptal puncture

  • "pig tail" catheter

  • "safe sept" guidewire

  • powered radiofrequency transseptal needle

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Transseptal Catheterization Registry. An Italian Overview
Actual Study Start Date :
Nov 20, 2022
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Jun 20, 2024

Arms and Interventions

Arm Intervention/Treatment
transseptal catheterization performed without auxiliary tools

patients in whom transseptal catheterization have been performed without auxiliary tools

Procedure: transseptal catheterization
puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.
Other Names:
  • transseptal puncture

    		•
    transseptal catheterization performed with auxiliary tools

    patients in who transseptal catheterization have been performed with the use of auxiliary tools

    Procedure: transseptal catheterization
    puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.
    Other Names:
  • transseptal puncture

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events related to inadvertent puncture cardiac structures other than atrial septum [Procedure time]

      absence of adverse events related to transseptal catheterization

    2. Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization [Procedure time]

      accomplishment fo transseptal catheterization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)
    Exclusion Criteria:
    • patients with learning disabilities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Presidio Ospedaliero G. Salesi Ancona Italy
    2 Ospedale Policlinico Sant'Orsola-Malpighi Bologna Italy 40138
    3 Spedali Civili di Brescia Brescia Italy 25123
    4 Ospedale Desenzano del Garda Desenzano Del Garda Italy 25015
    5 Ospedale San Raffaele Milano Italy
    6 Centro Cardiologico Monzino Milan Italy 20138
    7 Luigi Sacco University Hospital Milan Italy 20157
    8 Ospedale San Gerardo Monza Italy 20900
    9 Ospedale Policlinico Universitario Agostino Gemelli Roma Italy 00168
    10 Ospedale Di Circolo e Fondazione Macchi Varese Italy 21100

    Sponsors and Collaborators

    • Luigi Sacco University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gianfranco Mitacchione, Principal Investigator - Cardiac Electrophysiologist, Luigi Sacco University Hospital
    ClinicalTrials.gov Identifier:
    NCT05636046
    Other Study ID Numbers:
    • TITLE-registry
    First Posted:
    Dec 5, 2022
    Last Update Posted:
    Dec 5, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Gianfranco Mitacchione, Principal Investigator - Cardiac Electrophysiologist, Luigi Sacco University Hospital
    Catheter ablation
    Transseptal catheterization
    Additional relevant MeSH terms:
    Heart Diseases

    Study Results

    No Results Posted as of Dec 5, 2022