Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves (NCT02119442) | Clinical Trial Compass
CompletedNot Applicable
Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
United States90 participantsStarted 2013-08
Plain-language summary
A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments. The investigators plan to offer transcatheter valve implantation as an alternative to high risk surgery in patients who require revision of a stenotic or regurgitant valve in the non-pulmonary position (mitral, aortic, tricuspid). This therapy can provide an alternative to patients who may be considered high risk and may not be able to survive a surgical procedure.The use of the devices on this protocol are for medical treatment and are not part of a clinical trial.
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:
* Patients will be considered eligible for transcatheter valve implantation if the risk of serious morbidity or mortality with surgical intervention is deemed to be greater than 10 percent by the treating cardiologist and consulting surgeon. The Melody Valve is intended for use in the following clinical conditions:
* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, AND
* Dysfunctional RVOT conduits with a clinical indication for intervention, AND EITHER
* Regurgitation ≥ moderate
* Stenosis: mean right ventricular outflow tract gradient ≥ 35 mmHg
* The Edwards Sapien Valve will be used in the aortic position for valves and conduits larger than 23mm in diameter with a landing zone less than 26-27mm, otherwise the melody valve will be considered
* The Edwards Sapien Vavle will also be considered in other positions that have an adequate landing zone and a large enough circumference
* The Melody valve may be utilized outside of its approved indications for valve replacement in high risk surgical patients
Exclusion Criteria:
* There are no known contraindications for implantation of the Melody Valve or the Edwards Sapien Valve
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
Number of Participants Who Developed Infective Endocarditis