Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05122962

Conditions

Tetralogy of Fallot

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote Heart Rhythm Monitoring

Study Details

Brief summary:

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)

Conditions

Tetralogy of Fallot

Congenital Heart Disease

Study ID

NCT05122962

Start date

Nov 1, 2021

Status verified date

Feb, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Remote Heart Rhythm Monitoring

We will be looking to see if remote heart rhythm monitoring for 30 days at baseline, 12, and 24 months, helps for early identification of adverse cardiac events.

Primary outcome measure

  • Right Heart Remodeling [ Time Frame: 24 Months ]

Central Contacts and Locations

Central contacts

Halley Davison

507-422-6246RSTACHDRESPRG@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Halley Davison

507-422-6246RSTACHDRESPRG@mayo.edu

Principal Investigator:

Alexander Egbe, MBBS, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-05.