ArrhythmiaTITLENCT05636046
Transseptal Italian Registry (TITLE)
An observational study of Arrhythmia and Cardiac Disease, run by Luigi Sacco University Hospital at 10 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia, Cardiac Disease
- What is being tested?
- transseptal catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 10 sitesItaly
- Study dates
- 20 Nov 2022to 20 Jun 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients underwent trasseptal catheterization for catheter ablation of arrhythmias in the left heart
Who may be able to join
- patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)
Who cannot join
- patients with learning disabilities
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Enrolling by invitation
Presidio Ospedaliero G. Salesi
Ancona
- Enrolling by invitation
Ospedale Policlinico Sant'Orsola-Malpighi
Bologna, 40138
- Recruiting
Spedali Civili di Brescia
Brescia, 25123
Curnis Antonio, MD
- Recruiting
Ospedale Desenzano del Garda
Desenzano del Garda, 25015
Giosuè Mascioli, MD
- Enrolling by invitation
Centro Cardiologico Monzino
Milan, 20138
- Recruiting
Luigi Sacco University Hospital
Milan, 20157
Gianfranco Mitacchione, MD, PhD, 3394206452 ext. +39, gianfrancomit@hotmail.com
Gianfranco Mitacchione, MD, PhD
- Recruiting
Ospedale San Raffaele
Milan
Gulletta Simone, MD
- Recruiting
Ospedale San Gerardo
Monza, 20900
Rovaris Giovanni, MD
- Recruiting
Ospedale Policlinico Universitario Agostino Gemelli
Roma, 00168
Carlo Lavalle, MD
- Recruiting
Ospedale Di Circolo e Fondazione Macchi
Varese, 21100
Roberto De Ponti, MD
About this study
Official title: 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.
Read the detailed description
Data regarding transseptal catheterization in the Centers involved will be retrospectively collected over the past 10 years.
Will be collected:
- patients characteristics
- type of procedure requiring transseptal catheterization
- success rate
- adverse events
- use of tools for transseptal catheterization:
- intracardiac echocardiography (ICE) guidance
- simplified transseptal puncture
- "pig tail" catheter
- "safe sept" guidewire
- powered radiofrequency transseptal needle
- Conditions
- Arrhythmia, Cardiac Disease
- Being tested
- transseptal catheterization
- Keywords
- Catheter ablation, Transseptal catheterization
- Medical subject headings
- Arrhythmias, Cardiac, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transseptal catheterizationProcedure or surgery
Also called transseptal puncture
puncture of interatrial septum at the level of fossa ovalis, using transseptal needle.
| Study group | Role | What they receive |
|---|---|---|
| transseptal catheterization performed without auxiliary tools | patients in whom transseptal catheterization have been performed without auxiliary tools Receives: Procedure: transseptal catheterization | |
| transseptal catheterization performed with auxiliary tools | patients in who transseptal catheterization have been performed with the use of auxiliary tools Receives: Procedure: transseptal catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to inadvertent puncture cardiac structures other than atrial septum
absence of adverse events related to transseptal catheterization
Measured: Procedure time
Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization
accomplishment fo transseptal catheterization
Measured: Procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 Nov 2022
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Mitacchione, Luigi Sacco University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636046
- Sponsor's protocol ID
- TITLE-registry
- Acronym
- TITLE
- Status last verified
- Dec 2022
- First submitted
- 20 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transseptal Catheterization Registry. An Italian Overview
- ClinicalTrials.gov ID
- NCT05636046
- Acronym / sponsor ID
- TITLE / TITLE-registry
- Conditions
- Arrhythmia, Cardiac Disease
- Keywords
- Catheter ablation, Transseptal catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Data regarding transseptal catheterization in the Centers involved will be retrospectively collected over the past 10 years.
Will be collected:
- patients characteristics
- type of procedure requiring transseptal catheterization
- success rate
- adverse events
- use of tools for transseptal catheterization:
- intracardiac echocardiography (ICE) guidance
- simplified transseptal puncture
- "pig tail" catheter
- "safe sept" guidewire
- powered radiofrequency transseptal needle
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transseptal catheterization performed without auxiliary tools | – | Procedure: transseptal catheterizationpatients in whom transseptal catheterization have been performed without auxiliary tools |
| transseptal catheterization performed with auxiliary tools | – | Procedure: transseptal catheterizationpatients in who transseptal catheterization have been performed with the use of auxiliary tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients underwent trasseptal catheterization for catheter ablation of arrhythmias in the left heart
Key inclusion criteria (1 listed)
- patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)
Key exclusion criteria (1 listed)
- patients with learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transseptal catheterizationAlso: transseptal puncturepuncture of interatrial septum at the level of fossa ovalis, using transseptal needle. | Procedure or surgery | transseptal catheterization performed with auxiliary tools, transseptal catheterization performed without auxiliary tools |
Primary outcome
Adverse events related to inadvertent puncture cardiac structures other than atrial septum
Time frame: Procedure time
absence of adverse events related to transseptal catheterization
Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization
Time frame: Procedure time
accomplishment fo transseptal catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Arrhythmia
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Cardiac Disease, run by Luigi Sacco University Hospital at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Mitacchione, MD (3394206452 ext. +39, gianfrancomit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to inadvertent puncture cardiac structures other than atrial septum (time frame: Procedure time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.