Columbus, OHNCT05386173Now EnrollingIRB Ready

Congenital Heart Disease Clinical Trial in Columbus, OH

Access cutting-edge congenital heart disease treatment through this clinical trial at a research site in Columbus. Study-provided care at no cost to qualified participants.

Sponsored by Queen Silvia Children's Hospital, Gothenburg, Sweden

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Expert Care in Columbus

Access congenital heart disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related congenital heart disease treatment provided free

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Check if you qualify for this congenital heart disease clinical trial in Columbus, OH

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Why Participate?

  • No-Cost Study Care

  • Local to Columbus

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Columbus site if eligible
  4. 4Begin participation

About This Congenital Heart Disease Study in Columbus

In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective. The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.

Sponsor: Queen Silvia Children's Hospital, Gothenburg, Sweden

Who Can Participate

Inclusion Criteria

A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):
Aortic valve stenosis with antegrade flow through the valve
Predominantly left-to-right shunt at the atrial level
Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
Qualitatively depressed left ventricular function
Left ventricular end-diastolic diameter Z-score \> ±0
Left ventricular inlet length in diastole :
Gestational age ≤ 24+6: Z-score \> ±0
Gestational age 25+0 to 27+6: Z-score \> -0.75
Gestational age ≥ 28+0: Z-score \> -1.50
Mitral valve diameter in diastole Z-score \> -2.0 B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery

Exclusion Criteria

Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT05386173) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Congenital Heart Disease Treatment Options in Columbus, OH

If you're searching for congenital heart disease treatment options in Columbus, OH, this clinical trial (NCT05386173) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced congenital heart disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all congenital heart disease clinical trials near you to find additional studies recruiting in your area.

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