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Search / Trial NCT06588426

Clinical Readiness Skin Punch Biopsy Sample Collections

Launched by HEARTWORKS, INC. · Sep 6, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Chd Congenital Heart Defect

ClinConnect Summary

This clinical trial is focused on collecting skin samples using a small punch biopsy technique from patients with congenital heart disease (CHD) or congenital heart defects. The goal is to prepare for future treatments that these patients may qualify for in upcoming trials. By gathering these samples now, researchers hope to speed up the process of getting patients the treatment they need when they are matched with a new clinical study.

To participate in this trial, individuals must be at least 18 years old and have a diagnosis of congenital heart disease. They should also be likely to qualify for another clinical trial in the future. However, people who have had a heart transplant, are unable to give consent, or have certain infections like HIV or hepatitis cannot participate. If eligible, participants can expect a quick and simple procedure to collect the skin samples, which will help advance research and potentially lead to new treatment options for CHD.

Gender

ALL

Eligibility criteria

  • 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

About Heartworks, Inc.

HeartWorks, Inc. is a pioneering clinical trial sponsor focused on advancing cardiovascular healthcare through innovative research and development. Committed to improving patient outcomes, the company specializes in the design and execution of clinical trials that evaluate novel therapies and medical devices for heart-related conditions. With a team of experienced professionals and a robust network of clinical sites, HeartWorks, Inc. aims to facilitate the timely and efficient delivery of groundbreaking treatments, ensuring adherence to the highest standards of regulatory compliance and ethical practices. Through collaboration with healthcare providers, researchers, and regulatory bodies, HeartWorks, Inc. strives to enhance the quality of life for patients with cardiovascular diseases.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported