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
NCT06954792
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Medical Center
New York, New Yorkno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tamim Nazif, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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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.