Recruiting

Observational Study

Sponsor:

HeartWorks, Inc.

Code:

NCT06469918

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06469918

Start date

Jan 24, 2024

Status verified date

Oct, 2025

Completion date

Jan 1, 2050

Anticipated

Primary completion date

Jan 1, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

\- Not having a congenital heart defect/disease

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Central contacts

Adam Armstrong

(507) 577-1764adam@webuildhearts.org

Locations

HeartWorks, Inc.

Recruiting

Rochester, Minnesota, United States, 55901

Contacts

Clint Hagen, M.S.

(507) 577-1764clint@webuildhearts.org

More Information

Sponsor

HeartWorks, Inc.

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Keywords

  • HLHS
  • congenital heart defect
  • CHD
  • Hypoplastic left heart syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HeartWorks, Inc. on 2025-10-07.