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 : March 4, 2021
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.
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.
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
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:
Protected health data
Personally identifiable data
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|
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 Type :||Observational|
|Estimated Enrollment :||9999 participants|
|Official Title:||NHLBI Structural Heart and Valve Network Prospective Registry|
|Estimated Study Start Date :||March 9, 2021|
|Estimated Primary Completion Date :||December 20, 2028|
|Estimated Study Completion Date :||December 20, 2028|
All patients undergoing consultation for structural and valve interventional procedures are invited to participate in this registry protocol.
- 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.
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
|Contact: Robert J Lederman, M.D.||(301) firstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322-1102|
|Contact: Lauren Wheeler 404-712-7623 email@example.com|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|