Evaluating heart changes after a minimally invasive tricuspid valve repair
Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge Dell'Insufficienza Tricuspidale Severa
This study is testing how a new, less invasive heart procedure for severe tricuspid valve problems affects the shape and function of the right side of the heart in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan, Lombardia) |
| Trial ID | NCT06309524 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with severe secondary tricuspid regurgitation who are undergoing a transcatheter edge-to-edge repair using devices like the TriClip™ or PASCAL systems. The study aims to assess the impact of this minimally invasive procedure on the geometry and function of the right heart chambers through advanced imaging techniques such as 3D echocardiography and cardiac computed tomography. By monitoring these changes, the study seeks to provide insights into the effectiveness of the treatment and its potential benefits for patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe secondary tricuspid regurgitation suitable for percutaneous treatment.
Not a fit: Patients with severe chronic kidney disease, pregnancy, or those with inadequate echocardiographic imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how minimally invasive tricuspid valve repairs improve heart function and patient quality of life.
How similar studies have performed: Previous studies have shown promising results with similar minimally invasive approaches for tricuspid valve repair, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\> 18 years * Severe STR, amenable to percutaneous treatment with T-TEER * Acceptance to be part of this study by signing the informed consent * Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps * Availability for clinical, CCT and, echocardiography follow-up visits Exclusion Criteria: * Pregnancy * Severe chronic kidney disease (GFR \<30 mL/min) * Hypersensitivity reactions to contrast media * Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation. * Bad acoustic window with inadequate echocardiographic images.
Where this trial is running
Milan, Lombardia
- Istituto Auxologico Italiano — Milan, Lombardia, Italy (Recruiting)
Study contacts
- Study coordinator: Luca Grappiolo
- Email: luca.grappiolo@auxologico.it
- Phone: +390261911
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.