Mitral Valve RegurgitationNCT03928639
Structural Heart and Valve Network PROSPECTIVE Registry
An observational study of Mitral Valve Regurgitation and Heart Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mitral Valve Regurgitation, Heart Failure, Heart Valve Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Does not consent to participate in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- 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
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure, Heart Valve Diseases, Tricuspid Valve Insufficiency, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | All patients undergoing consultation for structural and valve interventional procedures are invited to participate in this registry protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start10 Jan 2023
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Why it stopped: Due to logistical issues at Emory University enrollment never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928639
- Sponsor's protocol ID
- 999919087
- Other IDs
- 19-H-N087
- Status last verified
- Jan 2023
- First submitted
- 25 Apr 2019
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHLBI Structural Heart and Valve Network Prospective Registry
- ClinicalTrials.gov ID
- NCT03928639
- Acronym / sponsor ID
- 999919087
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to logistical issues at Emory University enrollment never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –All patients undergoing consultation for structural and valve interventional procedures are invited to participate in this registry protocol. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Does not consent to participate in this protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Related trials for Mitral Valve Regurgitation
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
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Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Regurgitation and Heart Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.