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NCT Number: NCT06508866

Timing And Typology of ConducTIon disturbanCes During TAVI

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.

Recruiting

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Key information

Conditions

Aortic Stenosis, Severe Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Mangieri, MD

CONTACT

[email protected]

0282243084

Ottavia Cozzi, MD

CONTACT

[email protected]

0282247070

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: TACTIC-TAVI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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