Transcatheter treatments for tricuspid valve issues in Italy
TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
This study looks at how well transcatheter treatments for tricuspid valve problems work for patients in Italy by gathering information on their experiences and results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Locations | 1 site (Brescia, Lombardy) |
| Trial ID | NCT04735003 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from multiple centers in Italy on patients undergoing transcatheter interventions for tricuspid valve insufficiency. It aims to analyze clinical characteristics, procedural outcomes, and both short- and long-term results of these interventions in a real-world setting. The study includes both retrospective and prospective data collection to provide a comprehensive overview of patient experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing transcatheter treatment for tricuspid regurgitation, whether due to a native valve or a degenerated bioprosthesis.
Not a fit: Patients with valve anatomy unsuitable for transcatheter interventions or those unable to commit to follow-up visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of treatment outcomes for patients with tricuspid valve insufficiency, leading to better management strategies.
How similar studies have performed: Other studies on transcatheter interventions for heart valve issues have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brescia, Lombardy
- Marianna Adamo — Brescia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Marianna Adamo
- Email: mariannaadamo@hotmail.com
- Phone: +390303995564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.