The Co-Op @ HeartWorks

NCT ID: NCT06469918

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-24

Study Completion Date

2050-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeartWorks, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HeartWorks, Inc.

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Armstrong

Role: CONTACT

(507) 577-1764

Facility Contacts

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Clint Hagen, M.S.

Role: primary

(507) 577-1764

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Co-Op 001

Identifier Type: -

Identifier Source: org_study_id

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