Timing And Typology of ConducTIon disturbanCes During TAVI

NCT ID: NCT06508866

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis, Severe

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Mangieri, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Horspital

Locations

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IRCCS Istituo Clinico Humanitas

Rozzano, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Mangieri, MD

Role: CONTACT

0282243084

Ottavia Cozzi, MD

Role: CONTACT

0282247070

Facility Contacts

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Antonio Mangieri, MD

Role: primary

0282247085

Alessandra Cataldo, PhD

Role: backup

0282247085

Other Identifiers

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3328

Identifier Type: -

Identifier Source: org_study_id

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