Timing And Typology of ConducTIon disturbanCes During TAVI
ConditionAortic Stenosis, Severe
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
0-24 monthsSponsors and contacts
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Source ClinicalTrials.gov