NCT06954792
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Enrolling by Invitation
Not specifiedAges 18+ObservationalColumbia UniversityInvestigator-initiated
~140 participants
Updated 2026-02-12 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mortality Rate
Measured over 1 Year
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Tamim Nazif, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And
Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).
Exclusion
Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )
Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.
What this trial measures
- Mortality Rate1 Year
The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.