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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No AHI | Patients undergoing TTVR without presenting any AHI post-procedurally | ||
| AHI | Patients undergoing TTVR and presenting AHI within 24h after the procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) |
| Number of Participants with Right Ventricular (RV) Dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tamim Nazif, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| 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. | 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. | 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. | 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. | Within 48 hours after the procedure |
| Number of Participants with AHI | Number of Participants with AHI among all the population screened | Within 24 hours after the procedure |