Structural Heart and Valve Network PROSPECTIVE Registry

NCT03928639 | Withdrawn

• 2 other identifiers: 99991908719-H-N087
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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. ...

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

Outcome Measures

Primary Outcomes (1)

• Enrollment

  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.

  Ongoing

Study Arms (1)

Cohort 1

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• \- Does not consent to participate in this protocol.

Sponsors & Collaborators

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

Study Sites (1)

Emory University

Atlanta, Georgia, 30322-1102, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure; Heart Valve Diseases; Tricuspid Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 26, 2019
• Study Start: January 10, 2023
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

US (1)