Actively Recruiting
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Led by Mayo Clinic · Updated on 2026-02-05
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the causes behind symptoms like shortness of breath and palpitations, as well as changes in heart structure, in adults with congenital heart disease such as Tetralogy of Fallot and other related heart conditions. The study aims to better understand how these symptoms and heart changes develop over time. This observational study is sponsored by Mayo Clinic and focuses on the mechanisms that contribute to these health issues. Participants will undergo remote heart rhythm monitoring for 30 days at the start of the study, and again at 12 and 24 months. This monitoring is used to see if it can help identify early signs of adverse cardiac events. The study observes heart remodeling and measures aerobic capacity and the occurrence of arrhythmias over a 24-month period. During the study, participants will be assessed for right heart remodeling, incident arrhythmias, and aerobic capacity at scheduled intervals. The remote heart rhythm monitoring will help track heart activity continuously during monitoring periods. The total participation duration is 24 months, with evaluations designed to monitor heart function and symptoms related to congenital heart disease over time.
CONDITIONS
Brief Title
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of congenital heart disease, including Tetralogy of Fallot, Ebstein's anomaly, coarctation of the aorta, Fontan palliation, transposition of the great arteries, or congenitally corrected transposition of the great arteries
- Moderate or greater pulmonary regurgitation based on quantitative Doppler echocardiography
- Repaired Tetralogy of Fallot
You will not qualify if you...
- Pregnant women
- Unable to undergo cardiac magnetic resonance imaging (CMRI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 30 days at baseline, 12 months, and 24 months
Participants undergo remote heart rhythm monitoring to identify adverse cardiac events.
3 monitoring periods each lasting 30 days
Duration - 24 months
Participants are observed over 24 months to assess heart remodeling, arrhythmias, and aerobic capacity.
Assessments at baseline, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
H
Halley Davison
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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