The Co-Op @ HeartWorks

NCT06469918 | Recruiting

• 1 other identifier: Co-Op 001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Registry of individuals with CHD to plan and recruit for future interventional trials in Congenital Heart Defects/Disease

  25 years

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Human subjects with congenital heart disease

You may qualify if:

• 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

You may not qualify if:

• \- Not having a congenital heart defect/disease

Sponsors & Collaborators

• HeartWorks, Inc.: lead

Study Sites (1)

HeartWorks, Inc.

Rochester, Minnesota, 55901, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Adam Armstrong

CONTACT

(507) 577-1764; adam@webuildhearts.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2050
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)