United States, Canada, France1,312 participantsStarted 2014-05-12
Plain-language summary
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
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 has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
. Patient is geographically stable and willing to return to the implanting site for all follow-up visits
. Patient is of legal age to provide informed consent in the country where they enroll in the trial
. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
Exclusion criteria
. Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
. Patient presents with active endocarditis, active myocarditis or other systemic infection
. Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
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
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Timeframe: 1 year post-implant
2
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
3
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
Timeframe: Discharge (up to 30 days), 3-6 months, 1 year post-implant
4
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
5
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
Timeframe: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant
6
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
. Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2
. Patient has hyperparathyroidism
. Patient is participating in another investigational device or drug trial or observational competitive study
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
7
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
8
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
9
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant