Timing And Typology of ConducTIon disturbanCes During TAVI

NCT06508866 | Recruiting

• 1 other identifier: 3328
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis, Severe

Keywords

TAVI; Pacemaker; aortic stenosis

Outcome Measures

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.

  0-24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Istituo Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Antonio Mangieri, MD

  Humanitas Research Horspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Mangieri, MD

CONTACT

0282243084; antonio.mangieri@humanitas.it

Ottavia Cozzi, MD

CONTACT

0282247070; ottavia.cozzi@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 18, 2024
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

IT (1)