Clinical trial Recruiting at 1 site Observational Ages 18 and up

Understanding heart issues in patients with congenital heart disease

Official title: Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases

Run by Mayo Clinic · NCT05122962 · Data updated 2026-11-12

This study is trying to understand what causes symptoms like shortness of breath and palpitations in people with congenital heart disease, especially those with Tetralogy of Fallot, by using remote heart monitoring.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedNovember 1, 2021
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedFebruary 5, 2026
Trial IDNCT05122962 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with repaired Tetralogy of Fallot or other congenital heart diseases who exhibit moderate or greater pulmonary regurgitation.

Probably not a fit

Patients who are pregnant or unable to undergo cardiac MRI will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify the mechanisms that lead to symptoms such as shortness of breath and palpitations in patients with congenital heart disease, particularly those with Tetralogy of Fallot. It will utilize remote heart rhythm monitoring to gather data on heart structure and function. By analyzing these factors, the study seeks to improve understanding of how these conditions affect patients' health and quality of life.

Why it matters

Potential benefit: If successful, this study could lead to better management and treatment strategies for patients with congenital heart disease.

How similar studies have gone: Other studies have shown success in understanding arrhythmias and heart function in congenital heart disease, making this approach promising.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Moderate (or greater) PR based on quantitative Doppler echocardiography.
* Repaired TOF
* Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.

Exclusion Criteria:

* Pregnant Women
* Unable to undergo CMRI

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.