Transseptal Italian Registry (TITLE)

NCT ID: NCT05636046

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-20

Study Completion Date

2024-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmia Cardiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transseptal catheterization performed without auxiliary tools

patients in whom transseptal catheterization have been performed without auxiliary tools

transseptal catheterization

Intervention Type PROCEDURE

puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.

transseptal catheterization performed with auxiliary tools

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

transseptal catheterization

Intervention Type PROCEDURE

puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transseptal catheterization

puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

transseptal puncture

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* patients with learning disabilities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Luigi Sacco University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gianfranco Mitacchione

Principal Investigator - Cardiac Electrophysiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Presidio Ospedaliero G. Salesi

Ancona, , Italy

Site Status ENROLLING_BY_INVITATION

Ospedale Policlinico Sant'Orsola-Malpighi

Bologna, , Italy

Site Status ENROLLING_BY_INVITATION

Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Ospedale Desenzano del Garda

Desenzano del Garda, , Italy

Site Status RECRUITING

Centro Cardiologico Monzino

Milan, , Italy

Site Status ENROLLING_BY_INVITATION

Luigi Sacco University Hospital

Milan, , Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Ospedale San Gerardo

Monza, , Italy

Site Status RECRUITING

Ospedale Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status RECRUITING

Ospedale Di Circolo e Fondazione Macchi

Varese, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gianfranco Mitacchione, MD

Role: CONTACT

3394206452 ext. +39

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Curnis Antonio, MD

Role: primary

Giosuè Mascioli, MD

Role: primary

Gianfranco Mitacchione, MD, PhD

Role: primary

3394206452 ext. +39

Gulletta Simone, MD

Role: primary

Rovaris Giovanni, MD

Role: primary

Carlo Lavalle, MD

Role: primary

Roberto De Ponti, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TITLE-registry

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.