Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
(PACT Trial)
HD
Overseen ByHalley Davison
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)
Research Team
AE
Alexander Egbe, MBBS, MPH
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
I have moderate or severe pulmonary regurgitation as shown by an echocardiogram.
I have had surgery to correct my Tetralogy of Fallot.
I have been diagnosed with a congenital heart disease such as Ebstein's anomaly or coarctation of the aorta.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Observation
Participants are monitored for right heart remodeling and aerobic capacity over the course of the study
24 months
Follow-up
Participants are monitored for safety and effectiveness after the main observation period
4 weeks
Treatment Details
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Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Trials
3,987
Recruited
47,860,000+
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