Clinical trial NCT03928639: Structural Heart and Valve Network PROSPECTIVE Registry
Official title: NHLBI Structural Heart and Valve Network Prospective Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mitral Valve Regurgitation
Heart Failure
Heart Valve Disease
Tricuspid Valve Regurgitation
Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Mitral Valve Disease
Transcatheter Mitral Valve Replacement
Tricuspid Valve Disease
Transcatheter Mitral Valve Repair
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing consultation for structural and valve interventional procedures, at participating NHLBI structural heart and valve centers, are invited to participate in this registry protocol.

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.

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.

Primary outcomes:
measure: Enrollment
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Robert J Lederman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: