Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.
The secondary aim of the TVT Registry is to serve as a scalable data infrastructure forpost market studies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Valve Therapy | Device | Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | increase in the 30-day risk of adverse events among patients receiving TAVR | 30 days from procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Proportion of patients who are alive with at least moderate functional improvement (defined as at least 10 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline) at 1 year after receiving TAVR | 1 year |
| Major adverse cardiac and cerebrovascular events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colleen Balius | Contact | 9497641497 | colleen.balius@hoag.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoah Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
increase in the 1 year risk of adverse events among patients receiving TAVR |
| 1 year from procedure |