Transseptal Italian Registry (TITLE) (TITLE)

December 1, 2022 updated by: Gianfranco Mitacchione, Luigi Sacco University Hospital

Transseptal Catheterization Registry. An Italian Overview

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy
        • Enrolling by invitation
        • Presidio Ospedaliero G. Salesi
      • Bologna, Italy, 40138
        • Enrolling by invitation
        • Ospedale Policlinico Sant'Orsola-Malpighi
      • Brescia, Italy, 25123
        • Recruiting
        • Spedali Civili di Brescia
        • Contact:
          • Curnis Antonio, MD
      • Desenzano Del Garda, Italy, 25015
        • Recruiting
        • Ospedale Desenzano del Garda
        • Contact:
          • Giosuè Mascioli, MD
      • Milan, Italy, 20138
        • Enrolling by invitation
        • Centro Cardiologico Monzino
      • Milan, Italy, 20157
        • Recruiting
        • Luigi Sacco University Hospital
        • Contact:
        • Principal Investigator:
          • Gianfranco MItacchione, MD, PhD
        • Sub-Investigator:
          • Giovanni B Forleo, MD, PhD
      • Milano, Italy
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Gulletta Simone, MD
      • Monza, Italy, 20900
        • Recruiting
        • Ospedale San Gerardo
        • Contact:
          • Rovaris Giovanni, MD
      • Roma, Italy, 00168
        • Recruiting
        • Ospedale Policlinico Universitario Agostino Gemelli
        • Contact:
          • Carlo Lavalle, MD
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale Di Circolo E Fondazione Macchi
        • Contact:
          • Roberto De Ponti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients underwent trasseptal catheterization for catheter ablation of arrhythmias in the left heart

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with learning disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Sacco University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2022

Primary Completion (Anticipated)

November 20, 2023

Study Completion (Anticipated)

June 20, 2024

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TITLE-registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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