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Transseptal Italian Registry (TITLE)

L

Luigi Sacco University Hospital

Status

Enrolling

Conditions

Arrhythmia
Cardiac Disease

Treatments

Procedure: transseptal catheterization

Study type

Observational

Funder types

Other

Identifiers

NCT05636046
TITLE-registry

Details and patient eligibility

About

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.

Full 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

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)

Exclusion criteria

  • patients with learning disabilities

Trial design

1,000 participants in 2 patient groups

transseptal catheterization performed without auxiliary tools
Description:
patients in whom transseptal catheterization have been performed without auxiliary tools
Treatment:
Procedure: transseptal catheterization
transseptal catheterization performed with auxiliary tools
Description:
patients in who transseptal catheterization have been performed with the use of auxiliary tools
Treatment:
Procedure: transseptal catheterization

Trial contacts and locations

10

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Central trial contact

Gianfranco Mitacchione, MD

Data sourced from clinicaltrials.gov

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