Recruiting

Observational Study

Sponsor:

HeartWorks, Inc.

Code:

NCT06588426

Conditions

Congenital Heart Disease (CHD)

Congenital Heart Defect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Conditions

Congenital Heart Disease (CHD)

Congenital Heart Defect

Study ID

NCT06588426

Start date

Sep 13, 2024

Status verified date

Jun, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 and older
  • Congenital heart disease
  • Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion Criteria:

  • Previous cardiac transplantation
  • Unable or unwilling to consent
  • HIV diagnosis
  • Hepatitis diagnosis

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with congenital heart disease

Primary outcome measure

  • Successful manufacture of induced pluripotent stem cells [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Adam Armstrong

(507) 577-1764clinical@webuildhearts.org

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Karen Miller

507-266-6459HLHS@mayo.edu

Lori Riess

507-266-6459HLHS@mayo.edu

Principal Investigator:

Rebecca K Ameduri, M.D.

More Information

Sponsor

HeartWorks, Inc.

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Keywords

  • CHD
  • Congenital Heart Defect

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 2025-06-25.