Treatment for Congenital Heart Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Congenital Heart Disease+3 More
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the Medtronic Harmony TPV in people to see if it works as intended.

Eligible Conditions
  • Congenital Heart Disease
  • Tetralogy of Fallot
  • Right Ventricular Outflow Tract Anomaly
  • Pulmonary Regurgitation

Treatment Effectiveness

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 6 months

30-days
Number and percentage of subjects with procedure success at 30-days
6 months
Number and percentage of subjects with serious device-related adverse events at 6 months
Number and percentage of subjects with serious procedure- and device-related adverse events at 6 months
Percentage of subjects free from TPV dysfunction at 6-months
Percentage of subjects free from all-cause mortality at 6-months
Percentage of subjects free from catheter reintervention at 6-months
Percentage of subjects free from reoperation at 6-months
Proportion of subjects without valve intervention and with acceptable hemodynamic function composite at 6 months as defined by
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by

Trial Safety

Trial Design

0 Treatment Group

150 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
74 Previous Clinical Trials
36,317 Total Patients Enrolled
David Balzer, MDPrincipal InvestigatorSt. Louis Children's Hospital

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible to receive the Harmony TPV.
You are willing to participate in the study.