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Structural Heart and Valve Network PROSPECTIVE Registry

NHLBI Structural Heart and Valve Network Prospective Registry

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03928639
Enrollment
0
Registered
2019-04-26
Start date
2023-01-10
Completion date
2023-01-10
Last updated
2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Heart Failure, Heart Valve Disease, Mitral Valve Regurgitation, Tricuspid Valve Regurgitation

Keywords

Transcatheter Aortic Valve Replacement, Mitral Valve Disease, Transcatheter Mitral Valve Replacement, Tricuspid Valve Disease, Transcatheter Mitral Valve Repair, Natural History

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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
EnrollmentOngoingTo identify patients with common features of interest for further analysis, for example, of specific types of complications, and identifyshortcomings and patterns in clinical structural heart and valve interventional procedures.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026