Structural Heart and Valve Network PROSPECTIVE Registry

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
NCT03928639
Collaborator
(none)
9,999
Enrollment
1
Location
86
Anticipated Duration (Months)
116.3
Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:
Observational
Anticipated Enrollment :
9999 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
NHLBI Structural Heart and Valve Network Prospective Registry
Anticipated Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Dec 20, 2028
Anticipated Study Completion Date :
Dec 20, 2028

Arms and Interventions

ArmIntervention/Treatment
Cohort 1

All patients undergoing consultation for structural and valve interventional procedures are invited to participate in this registry protocol.

Outcome Measures

Primary Outcome Measures

  1. Enrollment [Ongoing]

    To 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Emory UniversityAtlantaGeorgiaUnited States30322-1102

Sponsors and Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Robert J Lederman, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT03928639
Other Study ID Numbers:
  • 999919087
  • 19-H-N087
First Posted:
Apr 26, 2019
Last Update Posted:
Oct 15, 2021
Last Verified:
Apr 19, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021