Collecting data on heart valve procedures for severe aortic stenosis

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

This study is collecting information from patients with severe aortic stenosis who are getting a new heart valve through a minimally invasive procedure to see how they do before and after the surgery.

Quick facts

• Study type: Observational
• Enrollment: 490 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Clinico Humanitas (other)
• Locations: 1 site (Rozzano, Milano)
• Trial ID: NCT06508866 on ClinicalTrials.gov

What this trial studies

The TACTIC-TAVI registry is an international, multi-centre observational project that gathers information on patients undergoing transcatheter aortic valve insertion for severe aortic stenosis. It aims to collect baseline clinical features, evaluate ECG and CT scan parameters, and document procedural characteristics, including any conduction disturbances. Additionally, the registry will follow up with post-procedural ECG, echocardiographic, and clinical outcomes until the target sample size is reached.

Who should consider this trial

Good fit: Ideal candidates are patients undergoing successful transcatheter aortic valve implantation for native severe aortic stenosis.

Not a fit: Patients with previously implanted permanent cardiac pacemakers or those undergoing valve-in-valve procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of conduction disturbances during TAVI, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown success in collecting data on TAVI procedures, indicating that this approach is supported by prior research.

Eligibility criteria

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. -

Where this trial is running

Rozzano, Milano

• IRCCS Istituo Clinico Humanitas — Rozzano, Milano, Italy (RECRUITING)

Study contacts

• Principal investigator: Antonio Mangieri, MD — Humanitas Research Horspital
• Study coordinator: Antonio Mangieri, MD

Conditions: Aortic Stenosis, Severe, TAVI, Pacemaker, aortic stenosis