Brief Title
Structural Heart and Valve Network PROSPECTIVE Registry
Official Title
NHLBI Structural Heart and Valve Network Prospective Registry
Brief Summary
Background: Treatments for structural heart and valve disease are quickly changing. But treatment could be improved. Researchers want to gather data from people with this disease. They want to find problems and seek new ways to make treatments better. Objective: To find people with structural heart and valve disease with common features to study. To find flaws and patterns in procedures related to this disease. To share findings with other researchers. Eligibility: People ages 18 and older who are receiving care from the structural heart and valve program at the participating NHLBI structural heart disease network sites that are part of the study Design: Participants will be screened with their consent. This will occur when they give their standard consent for medical care. Participants will have their data collected in the course of standard medical care. Data include: Demographic data Protected health data Personally identifiable data Medical records Medical images. These could include X-rays, CT scans, and MRI scans. The study could find something that would impact participants care. If this is the case, their doctors will be told. Participants data may be shared with other researchers. ...
Detailed Description
Medical care is evolving rapidly for patients considered for treatment of structural heart and valve disease. Despite technical advances, many shortcomings remain. This research protocol allows researchers to pool medical records and imaging studies to identify problems and seek new solutions. All patients considered for treatment at participating NHLBI structural heart and valve centers are invited to allow researchers to access their medical records repeatedly, including the results of medical procedures and imaging studies such as catheterization, CT, echocardiography, and MRI. These records, which include patient identity, will be sent to a central NHLBI database and kept confidential. Results will be used in medical publications but patient identity will be hidden.
Study Type
Observational
Primary Outcome
Enrollment
Condition
Mitral Valve Regurgitation
Study Arms / Comparison Groups
Cohort 1
Description: All patients undergoing consultation for structural and valve interventional procedures are invited to participate in this registry protocol.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
9999
Start Date
October 25, 2022
Completion Date
December 20, 2028
Primary Completion Date
December 20, 2028
Eligibility Criteria
- INCLUSION CRITERIA: - Adults age greater than or equal to 18 years. - Receiving care from the structural heart and valve program at the participating NHLBI structural heart disease network site. - Consent to participate in the protocol, directly, or through legally authorized representatives (LAR). EXCLUSION CRITERIA: - Does not consent to participate in this protocol.
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Robert J Lederman, M.D., (301) 402-6769, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03928639
Organization ID
999919087
Secondary IDs
19-H-N087
Responsible Party
Sponsor
Study Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor
Robert J Lederman, M.D., Principal Investigator, National Heart, Lung, and Blood Institute (NHLBI)
Verification Date
May 23, 2022