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Structural Heart and Valve Network PROSPECTIVE Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03928639
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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
Structural and Valve Disease

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.


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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 : August 27, 2019
Estimated Primary Completion Date : December 20, 2028
Estimated Study Completion Date : December 20, 2028

Group/Cohort
Cohort 1
All patients undergoing consultation for structural and valve interventional procedures are invited to participate in this registry protocol.



Primary Outcome Measures :
  1. 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. [ Time Frame: Ongoing ]
    To share imaging and other findings from clinical structural heart and valve interventional procedures among network participants and the broader scientific community. Ultimately these will be used to generate scientific communications such as medical papers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928639


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

Locations
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United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322-1102
Contact: Lauren Wheeler    404-712-7623    lmwheeler@emory.edu   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)

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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: August 22, 2019
Last Verified: April 17, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Transcatheter Aortic Valve Replacement
Mitral Valve Disease
Transcatheter Mitral Valve Replacement
Tricuspid Valve Disease