Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
TTVR-AHI
1 other identifier
observational
140
1 country
1
Brief Summary
TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2027
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2025
CompletedFirst Posted
Study publicly available on registry
May 2, 2025
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
Study Completion
Last participant's last visit for all outcomes
May 1, 2029
February 12, 2026
February 1, 2026
2.3 years
April 24, 2025
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality Rate
The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.
1 Year
Secondary Outcomes (7)
Number of Participants with Coronary Artery Disease (CAD)
Baseline (Day 0)
Number of Participants with Right Ventricular (RV) Dysfunction
Baseline (Day 0)
Number of Participants with Pulmonary Hypertension
Baseline (Day 0)
Number of Participants with Primary Left Ventricular Cardiomyopathy
Baseline (Day 0)
Number of Participants with Post-Procedural Fever
Within 48 hours after the procedure
- +2 more secondary outcomes
Study Arms (2)
No AHI
Patients undergoing TTVR without presenting any AHI post-procedurally
AHI
Patients undergoing TTVR and presenting AHI within 24h after the procedure
Eligibility Criteria
The study population represents TTVR patients presenting specifically an AHI after their intervention. In turn, the control group includes an all-comer population undergoing TTVR.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamim Nazif, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2025
First Posted
May 2, 2025
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
February 12, 2026
Record last verified: 2026-02