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WithdrawnNCT03928639Updated Jan 12, 2023

Structural Heart and Valve Network PROSPECTIVE Registry

An observational study in Mitral Valve Regurgitation, Heart Failure and Heart Valve Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Why this study was withdrawn
Due to logistical issues at Emory University enrollment never initiated.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

...

Read the 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.

02

Conditions studied

  • 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
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

Browse Aortic Valve Stenosis studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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.

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

EXCLUSION CRITERIA:

  • Does not consent to participate in this protocol.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Cohort 1

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

06

What researchers measure

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.

    Time frame: Ongoing

07

Study locations

1 site
  • Emory University
    Atlanta, Georgia 30322-1102, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03928639
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Apr 26, 2019
Start date
Jan 10, 2023
Primary completion
Jan 10, 2023
Completion
Jan 10, 2023
Last update
Jan 12, 2023

Study contacts

Robert J Lederman, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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