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Harmony TPV for Congenital Heart Disease
Study Summary
This trial will test the Medtronic Harmony TPV in people to see if it works as intended.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant, as confirmed by tests before certain procedures.My central veins are blocked.I have signs of an infection or active endocarditis.I had surgery to fix a heart valve issue with an RV-PA conduit.Your body cannot fit a specific size of medical tubing.You have an artificial heart valve or ring.You are able to use the Harmony TPV device according to the instructions in your area.I do not have a serious illness besides my cancer that would limit my life to under a year.I am scheduled for a procedure to place stents in my lung arteries.An ultrasound of your heart shows a mass, blood clot, or infection.You are planning to have the Harmony TPV implanted in your left heart.You are allergic to aspirin, heparin, or nickel.
- Group 1: Harmony TPV System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are eligible to join this experiment?
"To properly run this clinical trial, up to 150 qualified participants are necessary. Eligible patients can enrol in the study at Phoenix Children's in Phoenix or Boston Children's Hospital in Massachusetts."
Are researchers currently admitting participants for this trial?
"Affirmative. According to clinicaltrials.gov, this research endeavor, created on October 25th 2021, is still seeking volunteers. A total of 150 participants from 13 locations are needed for the study's completion."
How many health care centers are administering this research study?
"Across 13 sites, this medical trial is underway. Patients can find these locations in Phoenix, Boston and Charlottesville among other cities; it is recommended to choose a nearby clinic for convenience's sake."
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