NCT05122962

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2021Oct 2026

First Submitted

Initial submission to the registry

October 4, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

October 4, 2021

Last Update Submit

February 3, 2026

Conditions

Tetralogy of FallotCongenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Right Heart Remodeling

    Right Heart Remodeling measured via right atrial reservoir strain (%).

    24 Months

Secondary Outcomes (2)

  • Incident arrhythmias

    24 Months

  • Aerobic Capacity

    24 Months

Interventions

Remote Heart Rhythm MonitoringDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a prospective study of patients with congenital heart disease receiving care at Mayo Clinic Rochester, MN.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant Women
  • Unable to undergo CMRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Tetralogy of FallotHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexander Egbe, MBBS, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Halley Davison

CONTACT

507-422-6246RSTACHDRESPRG@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 17, 2021

Study Start

November 1, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)