Health TrialsbyHealthPanel

Transcatheter Interventions for Tricuspid Insufficiency in Italy

ConditionTricuspid Valve Insufficiency
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorMarianna Adamo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter tricuspid valve interventions

    Device

    Transcatheter repair or replacement to treat tricuspid regurgitation

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marianna Adamo

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Sponsor institution

San Raffaele University Hospital, Italy

Collaborator

Source ClinicalTrials.gov
Apply now