Congenital Heart DiseaseNCT06469918
The Co-Op @ HeartWorks
An observational study of Congenital Heart Disease, run by HeartWorks, Inc. at 1 site in United States.
Trial summary
This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 1 Jan 2050
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Human subjects with congenital heart disease
Who may be able to join
- Adult with a congenital heart defects/disease
- Caregiver of a minor with a congenital heart defect/disease
- Authorized family member of a now deceased person with congenital heart defect/disease
Who cannot join
- Not having a congenital heart defect/disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HeartWorks, Inc.
Rochester, Minnesota, 55901
Clint Hagen, M.S., (507) 577-1764, clint@webuildhearts.org
About this study
This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-Op @ HeartWorks members. Unlike a traditional disease registry, the members of The Co-Op @ HeartWorks will actively inform and contribute to the future studies affecting their health.
- Conditions
- Congenital Heart Disease
- Keywords
- HLHS, congenital heart defect, CHD, Hypoplastic left heart syndrome
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Registry of individuals with CHD to plan and recruit for future interventional trials in Congenital Heart Defects/Disease
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start24 Jan 2024
- Primary completion1 Jan 2050 (estimated)
- Study completion1 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- HeartWorks, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469918
- Sponsor's protocol ID
- Co-Op 001
- Status last verified
- Oct 2025
- First submitted
- 14 Jun 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Co-Op @ HeartWorks
- ClinicalTrials.gov ID
- NCT06469918
- Acronym / sponsor ID
- Co-Op 001
- Conditions
- Congenital Heart Disease
- Keywords
- HLHS, congenital heart defect, CHD, Hypoplastic left heart syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- HeartWorks, Inc.University, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Jan 2050 (estimated)
- Study completion
- 1 Jan 2050 (estimated)
- First posted
- 24 Jun 2024 (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.
This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-Op @ HeartWorks members. Unlike a traditional disease registry, the members of The Co-Op @ HeartWorks will actively inform and contribute to the future studies affecting their health.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 25 Years
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Human subjects with congenital heart disease
Key inclusion criteria (3 listed)
- Adult with a congenital heart defects/disease
- Caregiver of a minor with a congenital heart defect/disease
- Authorized family member of a now deceased person with congenital heart defect/disease
Key exclusion criteria (1 listed)
- Not having a congenital heart defect/disease
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
Registry of individuals with CHD to plan and recruit for future interventional trials in Congenital Heart Defects/Disease
Time frame: 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Congenital Heart Disease, run by HeartWorks, Inc. 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Armstrong ((507) 577-1764, adam@webuildhearts.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry of individuals with CHD to plan and recruit for future interventional trials in Congenital Heart Defects/Disease (time frame: 25 years). 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 7 Oct 2025.