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NCT05636046 Clinical Trial

Transseptal Italian Registry (TITLE)

Cardiac Disease Clinical Trial

— TITLE  

Official title:
Transseptal Catheterization Registry. An Italian Overview

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05636046
Other study ID # TITLE-registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 20, 2022
Est. completion date June 20, 2024

Study information
Verified date December 2022
Source Luigi Sacco University Hospital
Contact Gianfranco Mitacchione, MD
Phone 3394206452
Email gianfrancomit@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date June 20, 2024
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation) Exclusion Criteria: - patients with learning disabilities

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Presidio Ospedaliero G. Salesi Ancona
Italy Ospedale Policlinico Sant'Orsola-Malpighi Bologna
Italy Spedali Civili di Brescia Brescia
Italy Ospedale Desenzano del Garda Desenzano Del Garda
Italy Centro Cardiologico Monzino Milan
Italy Luigi Sacco University Hospital Milan
Italy Ospedale San Raffaele Milano
Italy Ospedale San Gerardo Monza
Italy Ospedale Policlinico Universitario Agostino Gemelli Roma
Italy Ospedale Di Circolo e Fondazione Macchi Varese

Sponsors (1)
Lead Sponsor Collaborator
Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events related to inadvertent puncture cardiac structures other than atrial septum absence of adverse events related to transseptal catheterization Procedure time
Primary Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization accomplishment fo transseptal catheterization Procedure time
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