Transseptal Italian Registry (TITLE)
TITLE
Transseptal Catheterization Registry. An Italian Overview
1 other identifier
observational
1,000
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
10 active sites
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
First Submitted
Initial submission to the registry
November 20, 2022
CompletedStudy Start
First participant enrolled
November 20, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedDecember 5, 2022
December 1, 2022
1 year
November 20, 2022
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse events related to inadvertent puncture cardiac structures other than atrial septum
absence of adverse events related to transseptal catheterization
Procedure time
Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization
accomplishment fo transseptal catheterization
Procedure time
Study Arms (2)
transseptal catheterization performed without auxiliary tools
patients in whom transseptal catheterization have been performed without auxiliary tools
transseptal catheterization performed with auxiliary tools
patients in who transseptal catheterization have been performed with the use of auxiliary tools
Interventions
puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.
Eligibility Criteria
all patients underwent trasseptal catheterization for catheter ablation of arrhythmias in the left heart
You may qualify if:
- patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)
You may not qualify if:
- patients with learning disabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Presidio Ospedaliero G. Salesi
Ancona, Italy
Ospedale Policlinico Sant'Orsola-Malpighi
Bologna, 40138, Italy
Spedali Civili di Brescia
Brescia, 25123, Italy
Ospedale Desenzano del Garda
Desenzano del Garda, 25015, Italy
Centro Cardiologico Monzino
Milan, 20138, Italy
Luigi Sacco University Hospital
Milan, 20157, Italy
Ospedale San Raffaele
Milan, Italy
Ospedale San Gerardo
Monza, 20900, Italy
Ospedale Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Ospedale Di Circolo e Fondazione Macchi
Varese, 21100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator - Cardiac Electrophysiologist
Study Record Dates
First Submitted
November 20, 2022
First Posted
December 5, 2022
Study Start
November 20, 2022
Primary Completion
November 20, 2023
Study Completion
June 20, 2024
Last Updated
December 5, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share