Transcutaneous Valve Therapies
Conditions
Brief summary
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.
Detailed description
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.
Interventions
DEVICETranscutaneous Valve Therapy
Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.
Sponsors
Hoag Memorial Hospital Presbyterian
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | 30 days from procedure | increase in the 30-day risk of adverse events among patients receiving TAVR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | 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 |
| Major adverse cardiac and cerebrovascular events | 1 year from procedure | increase in the 1 year risk of adverse events among patients receiving TAVR |
Countries
United States
Contacts
Primary ContactColleen Balius
Outcome results
None listed