ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent (NCT03130777) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
United States86 participantsStarted 2017-08-22
Plain-language summary
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the 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
. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
. Weight is ≥ 20 kg (44 lbs).
. RVOT/PV with moderate or greater PR by TTE.
. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.
Exclusion criteria
. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
. History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
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.
. Leukopenia (WBC \< 2000 cells/μL), anemia (Hgb \< 7 g/dL), thrombocytopenia (platelets \< 50,000 cells/μL) or any known blood clotting disorder.
. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure
. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure