Status:
NOT_YET_RECRUITING
Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function
Lead Sponsor:
Francesco Maisano
Collaborating Sponsors:
IRCCS Ospedale San Raffaele
Abbott
Conditions:
Tricuspid Regurgitation (TR)
Eligibility:
All Genders
18+ years
Brief Summary
Tricuspid regurgitation (TR) is gaining increasing attention within the cardiological community due to its poor prognosis, challenging clinical presentation and difficult treatment. TR causes decreas...
Eligibility Criteria
Inclusion
- Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.
Exclusion
- Concomitant ≥ severe MR. Such patients may be treated with M-TEER and be re-evaluated after 3 months: if TR is ≥ severe and MR is ≤ moderate the patient may then be enrolled.
- Surgical candidates
- Recent \< 6 months cardiac coronary or structural procedure
- CAD requiring intervention
- other valvular disease \> moderate
- Treatment with transcatheter tricuspid replacement
- Age \<18 years
- Inability or unwillingness to sign informed consent
- Kidney dialysis
- Acute infection
- Inflammatory bowel diseases
- Gastrointestinal diseases
- Previous gastrointestinal surgery
- Active cancer
- Active autoimmune or inflammatory diseases
- Treatments with antibiotics or probiotics within one month
- Emergency procedures
- Patients enrolled in interventional studies that may confound study results
Key Trial Info
Start Date :
March 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06902922
Start Date
March 31 2025
End Date
September 30 2027
Last Update
March 30 2025
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132