Timing And Typology of ConducTIon disturbanCes During TAVI

Recruiting

• Conditions: Aortic Stenosis, Severe

• Registration Number: NCT06508866
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-18
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

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. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS Istituo Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy