Transcatheter treatments for tricuspid valve issues in Italy
Official title: TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
Run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · NCT04735003 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Locations | 1 site (Brescia, Lombardy) |
| Status | Recruiting |
| Started | January 30, 2021 |
| Main results expected | January 30, 2026 |
| Study ends | January 30, 2027 |
| Registry record updated | February 2, 2021 |
| Trial ID | NCT04735003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients undergoing transcatheter treatment for tricuspid regurgitation, whether due to a native valve or a degenerated bioprosthesis.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies on transcatheter interventions for heart valve issues have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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Marianna Adamo
Brescia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Marianna Adamo
- Email: mariannaadamo@hotmail.com
- Phone: +390303995564
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TruGamma tricuspid valve replacement for high-risk patients
This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.
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Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation
This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.
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Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation
This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.
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Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults
This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
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Korea VHD Echo Study: Real-World Practice of Aortic, Mitral, and Tricuspid Valves
This study looks at how valvular heart disease is managed in Korea by reviewing echocardiograms and medical records from multiple centers to see patterns in disease progression and treatment.
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Investigating multiple and mixed heart valve diseases
This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.