N/A
N=211
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00820599 ↗Enrolled (actual)
211
Serious AEs
91.5%
Results posted
Nov 2020
Primary outcome: Primary: Number of Deaths — 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sapien XT™ transcatheter heart valve and delivery system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Deaths |
21 | — |
| SECONDARY Number of Participants With a Stroke |
9 | — |
Summary
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.
Eligibility Criteria
Inclusion Criteria
All candidates for this study must meet all of the following inclusion criteria:
- Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is > 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of > 20%.
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
- Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion Criteria
- Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).
Data sourced from ClinicalTrials.gov (NCT00820599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.