Timing And Typology of ConducTIon disturbanCes During TAVI (TACTIC-TAVI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis, Severe

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 Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Antonio Mangieri, MD; Phone Number: 0282243084; Email: antonio.mangieri@humanitas.it
• Study Contact Backup: Name: Ottavia Cozzi, MD; Phone Number: 0282247070; Email: ottavia.cozzi@humanitas.it

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • IRCCS Istituo Clinico Humanitas
      • Contact: Antonio Mangieri, MD; Phone Number: 0282247085; Email: antonio.mangieri@humanitas.it
      • Contact: Alessandra Cataldo, PhD; Phone Number: 0282247085; Email: alessandra.cataldo@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

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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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonio Mangieri, MD, Humanitas Research Horspital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: aortic stenosis; TAVI; Pacemaker
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 3328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No