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NCT Number: NCT04735003

Transcatheter Interventions for Tricuspid Insufficiency in Italy

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.

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Key information

Conditions

Tricuspid Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marianna Adamo

Brescia, Lombardy, 25123, Italy

Location status: Recruiting

Location contact

Marianna Adamo

CONTACT

[email protected]

+390303995564

Marianna Adamo

PRINCIPAL_INVESTIGATOR

Paolo Denti

CONTACT

[email protected]

Paolo Denti

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Transcatheter tricuspid valve interventions

Device

Transcatheter repair or replacement to treat tricuspid regurgitation

Primary outcomes

  1. All-cause death

    Time frame: 1-year

  2. Cardiovascular death or heart failure hospitalization

    Time frame: 1-year

Secondary outcomes

  1. Changes in tricuspid regurgitation degree

    Time frame: 30-day, 1-year and 5-year

  2. Changes in NYHA class

    Time frame: 30-day, 1-year and 5-year

  3. Changes in right ventricular dimensions and function

    Time frame: 30-day, 1-year and 5-year

  4. Changes in liver and kidney function

    Time frame: 30-day, 1-year and 5-year

  5. Changes in medical therapy (i.e. diuretic dose)

    Time frame: 30-day, 1-year and 5-year

  6. All-cause death

    Time frame: 30-day

  7. All-cause death

    Time frame: 5-year

  8. Cardiovascular death or heart failure hospitalization

    Time frame: 30-day

  9. Cardiovascular death or heart failure hospitalization

    Time frame: 5-year

Study contacts

Contact information is provided by the study sponsor or research team.

Marianna Adamo

CONTACT

[email protected]

+390303995564

Paolo Denti

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Marianna Adamo

Other

Collaborators

  • San Raffaele University Hospital, Italy

Registry information

Official study title

TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study

Acronym: TRIC-IT

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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