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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Structural Heart and Valve Network PROSPECTIVE Registry

Clinicaltrials.gov identifier NCT03928639

Recruitment Status Not yet recruiting

First Posted April 26, 2019

Last update posted October 13, 2020

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. ...

  • Condition or Disease:Mitral Valve Regurgitation
    Heart Failure
    Heart Valve Disease
    Tricuspid Valve Regurgitation
    Aortic Valve Stenosis
  • Intervention/Treatment:
  • Phase: N/A
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
  • Estimated Enrollment: 9999 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: NHLBI Structural Heart and Valve Network Prospective Registry
  • Estimated Study Start Date: October 2020
  • Estimated Primary Completion Date: December 2028
  • Estimated Study Completion Date: December 2028
Outcome Measures
  • Primary Outcome Measures: 1. Enrollment [ Time Frame: 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
  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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.

Contacts and Locations
Contacts

Contact: Robert J Lederman, M.D. (301) 402-6769 lederman@nih.gov

Locations

United States, Georgia
Emory University
Atlanta

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)

More Information
  • Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
  • ClinicalTrials.gov Identifier: NCT03928639 History of Changes
  • Other Study ID Numbers: 999919087, 19-H-N087
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: October 13, 2020
  • Last Verified: March 2020
  • 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): Transcatheter Aortic Valve Replacement
    Mitral Valve Disease
    Transcatheter Mitral Valve Replacement
    Tricuspid Valve Disease
    Transcatheter Mitral Valve Repair
  • Additional relevant MeSH terms: Aortic Valve Stenosis
    Heart Valve Diseases
    Mitral Valve Insufficiency
    Tricuspid Valve Insufficiency