NCT06508866RecruitingNot Applicable
Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry
Istituto Clinico Humanitas1 site in 1 country490 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 490
- Locations
- 1
- Primary Endpoint
- Prediction of new requirement for permanent pacemaker after TAVI
Study Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.
Exclusion Criteria
- •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. -
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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