Structural Heart and Valve Network PROSPECTIVE Registry

NHLBI Structural Heart and Valve Network Prospective Registry

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.

...

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Aortic Valve Stenosis; Mitral Valve Regurgitation; Heart Valve Disease; Tricuspid Valve Regurgitation

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322-1102
      • Emory University
      • Contact: Lauren Wheeler; Phone Number: 404-712-7623; Email: lmwheeler@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Natural History; Transcatheter Aortic Valve Replacement; Mitral Valve Disease; Transcatheter Mitral Valve Replacement; Tricuspid Valve Disease; Transcatheter Mitral Valve Repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Mitral Valve Insufficiency; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 999919087; 19-H-N087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No