Transcatheter Interventions for Tricuspid Insufficiency in Italy

NCT ID: NCT04735003

Last Updated: 2021-02-02

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-30

Study Completion Date

2027-01-30

Brief Summary

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This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.

Detailed Description

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Conditions

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Tricuspid Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcatheter tricuspid valve interventions

Transcatheter repair or replacement to treat tricuspid regurgitation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
2. Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.

Exclusion Criteria

1. Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
2. Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Raffaele University Hospital, Italy

OTHER

Sponsor Role collaborator

Marianna Adamo

OTHER

Sponsor Role lead

Responsible Party

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Marianna Adamo

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Marianna Adamo

Brescia, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marianna Adamo

Role: CONTACT

+390303995564

Paolo Denti

Role: CONTACT

Facility Contacts

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Marianna Adamo

Role: primary

+390303995564

Paolo Denti

Role: backup

Other Identifiers

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581011977013

Identifier Type: -

Identifier Source: org_study_id

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