Timing And Typology of ConducTIon disturbanCes During TAVI

Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06508866

Acronym

TACTIC-TAVI

Enrollment

490

Registered

2024-07-18

Start date

2023-02-01

Completion date

2024-12-31

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Severe

Keywords

TAVI, Pacemaker, aortic stenosis

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: 1. collect the baseline clinical features of the study population. 2. evaluate the electrocardiogram (ECG) and contrast tomography (CT) scan parameters. 3. collect procedural characteristics including type and timing of any conduction disturbance 4. collect follow-up data including post-procedural ECG, echocardiographic and clinical outcomes.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

Patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis. \-

Exclusion criteria

1. Presence of previously implanted permanent cardiac pacemaker. 2. Valve-in-valve procedures. 3. No pre-procedural electrocardiogram is available. 4. No pre-procedural contrast CT TAVI is available. 5. Enrollment in another clinical trial. 6. Patients aged less than 18 years old. 7. Patients who do not consent for their data to be included in the registry. 8. Failed transcatheter aortic valve deployment. -

Design outcomes

Primary

Measure	Time frame	Description
Prediction of new requirement for permanent pacemaker after TAVI	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.

Countries

Italy

Contacts

Primary ContactAntonio Mangieri, MD

antonio.mangieri@humanitas.it0282243084

Backup ContactOttavia Cozzi, MD

ottavia.cozzi@humanitas.it0282247070

Outcome results