JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study (NCT02732691) | Clinical Trial Compass
UnknownNot Applicable
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
United States, Germany, Netherlands68 participantsStarted 2016-10-21
Plain-language summary
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
Who can participate
Age range
18 Years
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:
* Patient with severe degenerative native aortic stenosis (AS).
* Patient at high risk for open surgical valve replacement
* Patient symptomatic according to NYHA functional class II or higher
Exclusion Criteria:
* Congenital uni- or bicuspid aortic valve morphology
* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
* Endocarditis or other active infection
* Need for urgent or emergent TAVR procedure for any reason
* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
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.