N/A
N=1,015
CoreValve Advance International Post Market Study
Severe Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01074658 ↗Enrolled (actual)
1,015
Serious AEs
54.3%
Results posted
Oct 2016
Primary outcome: Primary: Major Adverse Cardiac & Cerebrovascular Events (MACCE) — 92 Freedom from MACCE (%) @30days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Medtronic CoreValve System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiac & Cerebrovascular Events (MACCE) |
92 | — |
| SECONDARY Percentage of Participants With Device Success |
79.4 | — |
| SECONDARY Percentage of Participants With Procedural Success |
71.1 | — |
Summary
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
Eligibility Criteria
Inclusion Criteria
- Patients with severe aortic valve stenosis requiring treatment
- Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
- Patient is above the minimum age as required by local regulations to be participating in a clinical study
- The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
Exclusion Criteria
- Currently participating in another trial
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01074658). 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.