Aortic Stenosis, SevereTACTIC-TAVINCT06508866
Timing And Typology of ConducTIon disturbanCes During TAVI
An observational study of Aortic Stenosis, Severe, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe
- How many people
- 490 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 31 Dec 2024
- 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
- Adult, Older adult
Study population: The study is a retrospective and prospective registry aiming to observe intra-procedural conduction disturbances in patients undergoing TAVI for severe aortic stenosis. Patients will have no alteration to standard post-procedural management and will their have usual follow-up. There are four key time points: 1) pre-procedure 2) intra-procedure 3) post-procedure 4) discharge. The electrocardiogram will be assessed at timepoints 1-3 and requirement for permanent pacemaker insertion by timepoint 4.
Who may be able to join
- Patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.
- -
Who cannot join
- Presence of previously implanted permanent cardiac pacemaker.
- Valve-in-valve procedures.
- No pre-procedural electrocardiogram is available.
- No pre-procedural contrast CT TAVI is available.
- Enrollment in another clinical trial.
- Patients aged less than 18 years old.
- Patients who do not consent for their data to be included in the registry.
- Failed transcatheter aortic valve deployment. -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituo Clinico Humanitas
Rozzano, Milano, 20089
Antonio Mangieri, MD, 0282247085, antonio.mangieri@humanitas.it
Alessandra Cataldo, PhD, 0282247085, alessandra.cataldo@humanitas.it
About this study
Official title: Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry
The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.
Read the detailed description
All patients since February 2023 treated successfully with TAVI until the study endpoint will be deemed suitable for inclusion in the registry. The registry will:
- collect the baseline clinical features of the study population.
- evaluate the electrocardiogram (ECG) and contrast tomography (CT) scan parameters.
- collect procedural characteristics including type and timing of any conduction disturbance
- collect follow-up data including post-procedural ECG, echocardiographic and clinical outcomes.
- Conditions
- Aortic Stenosis, Severe
- Keywords
- TAVI, Pacemaker, aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of new requirement for permanent pacemaker after TAVI
The primary focus of the registry is evaluating which patient characteristics and conduction disturbances may help to predict the new requirement for permanent pacemaker after TAVI.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Mangieri, MD, Principal investigator, Humanitas Research Horspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508866
- Sponsor's protocol ID
- 3328
- Acronym
- TACTIC-TAVI
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry
- ClinicalTrials.gov ID
- NCT06508866
- Acronym / sponsor ID
- TACTIC-TAVI / 3328
- Conditions
- Aortic Stenosis, Severe
- Keywords
- TAVI, Pacemaker, aortic stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jul 2024 (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 TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.
Detailed description
All patients since February 2023 treated successfully with TAVI until the study endpoint will be deemed suitable for inclusion in the registry. The registry will:
- collect the baseline clinical features of the study population.
- evaluate the electrocardiogram (ECG) and contrast tomography (CT) scan parameters.
- collect procedural characteristics including type and timing of any conduction disturbance
- collect follow-up data including post-procedural ECG, echocardiographic and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study is a retrospective and prospective registry aiming to observe intra-procedural conduction disturbances in patients undergoing TAVI for severe aortic stenosis. Patients will have no alteration to standard post-procedural management and will their have usual follow-up. There are four key time points: 1) pre-procedure 2) intra-procedure 3) post-procedure 4) discharge. The electrocardiogram will be assessed at timepoints 1-3 and requirement for permanent pacemaker insertion by timepoint 4.
Key inclusion criteria (2 listed)
- Patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.
- -
Key exclusion criteria (8 listed)
- Presence of previously implanted permanent cardiac pacemaker.
- Valve-in-valve procedures.
- No pre-procedural electrocardiogram is available.
- No pre-procedural contrast CT TAVI is available.
- Enrollment in another clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of new requirement for permanent pacemaker after TAVI
Time frame: 0-24 months
The primary focus of the registry is evaluating which patient characteristics and conduction disturbances may help to predict the new requirement for permanent pacemaker after TAVI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
Antonio Mangieri, MD principal investigator
Humanitas Research Horspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, Severe, run by Istituto Clinico Humanitas at 1 site 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 2 inclusion and 8 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Antonio Mangieri, MD (0282243084, antonio.mangieri@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of new requirement for permanent pacemaker after TAVI (time frame: 0-24 months). 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 22 Jul 2024.