Structural Heart and Valve Network PROSPECTIVE Registry

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Not yet recruiting

CT.gov ID

NCT03928639

Collaborator

(none)

9,999

Enrollment

Location

73.9

Anticipated Duration (Months)

135.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Mitral Valve Regurgitation Heart Failure Heart Valve Disease Tricuspid Valve Regurgitation Aortic Valve Stenosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

9999 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NHLBI Structural Heart and Valve Network Prospective Registry

Anticipated Study Start Date :

Oct 25, 2022

Anticipated Primary Completion Date :

Dec 20, 2028

Anticipated Study Completion Date :

Dec 20, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Enrollment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).