The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study (NCT02979587) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
United States, Canada, Japan86 participantsStarted 2017-01
Plain-language summary
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction \>/= 30%
* Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
* Subject is willing to consent to participate
Exclusion Criteria:
* Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
* RVOT anatomy or morphology that is unfavorable for device anchoring
* Positive pregnancy test
* Life expectancy of less than 1 year
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom From Procedure- or Device-related Mortality at 30 Days.
Timeframe: 30 days
2
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months