Tricuspid RegurgitationTTVR-AHINCT06954792
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
An observational study of Tricuspid Regurgitation and Heart Failure, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Heart Failure, Structural Heart Disease
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
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).
Read the detailed description
TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.
- Conditions
- Tricuspid Regurgitation, Heart Failure, Structural Heart Disease, Interventional Cardiology
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No AHI | Patients undergoing TTVR without presenting any AHI post-procedurally | |
| AHI | Patients undergoing TTVR and presenting AHI within 24h after the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.
Measured: 1 Year
Secondary outcomes (7)
Number of Participants with Coronary Artery Disease (CAD)
Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population.
The number of participants with CAD will be reported.
Measured: Baseline (Day 0)
Number of Participants with Right Ventricular (RV) Dysfunction
Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population.
The number of participants with RV dysfunction will be reported.
Measured: Baseline (Day 0)
Number of Participants with Pulmonary Hypertension
Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with pulmonary hypertension will be reported.
Measured: Baseline (Day 0)
Number of Participants with Primary Left Ventricular Cardiomyopathy
Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with primary left ventricular cardiomyopathy will be reported.
Measured: Baseline (Day 0)
Number of Participants with Post-Procedural Fever
The number of participants with post-procedural fever will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis.
Measured: Within 48 hours after the procedure
Number of Participants with Post-procedural Inflammatory Response
The number of participants with post-procedural inflammatory response will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis.
Measured: Within 48 hours after the procedure
Number of Participants with AHI
Number of Participants with AHI among all the population screened
Measured: Within 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study startJan 2027 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamim Nazif, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954792
- Sponsor's protocol ID
- AAAV0931
- Acronym
- TTVR-AHI
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
- ClinicalTrials.gov ID
- NCT06954792
- Acronym / sponsor ID
- TTVR-AHI / AAAV0931
- Conditions
- Tricuspid Regurgitation, Heart Failure, Structural Heart Disease, Interventional Cardiology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No AHI | – | –Patients undergoing TTVR without presenting any AHI post-procedurally |
| AHI | – | –Patients undergoing TTVR and presenting AHI within 24h after the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality Rate
Time frame: 1 Year
The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.
7 secondary outcomes
Number of Participants with Coronary Artery Disease (CAD)
Time frame: Baseline (Day 0)
Number of Participants with Right Ventricular (RV) Dysfunction
Time frame: Baseline (Day 0)
Number of Participants with Pulmonary Hypertension
Time frame: Baseline (Day 0)
Number of Participants with Primary Left Ventricular Cardiomyopathy
Time frame: Baseline (Day 0)
Number of Participants with Post-Procedural Fever
Time frame: Within 48 hours after the procedure
Number of Participants with Post-procedural Inflammatory Response
Time frame: Within 48 hours after the procedure
Number of Participants with AHI
Time frame: Within 24 hours after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamim Nazif, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation and Heart Failure, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.