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|
| General |
| Study Status |
Revised/Replaced Study |
| Application Number |
P130021 / PAS002 |
| Date Current Protocol Accepted |
02/17/2014
|
| Study Name |
Continued f/u of continued access cohort
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Design Description |
A longitudinal observational clinical trial following subjects that were enrolled in the Medtronic CoreValve® Continued Access Study (CAS) and received the Medtronic CoreValve® System (MCS).
Not a hypothesis driven study.
|
| Study Population Description |
Extreme risk subjects currently consented to and enrolled in the Medtronic U.S. CAS Protocol, and implanted with the MCS.
|
| Sample Size |
All subjects enrolled in the CoreValve® Continued Access Study (approximately 2250, including both ilio-femoral and non-ilio-femoral implant access) at all sites (up to 45).
|
| Data Collection |
Primary endpoints: all-cause death or major stroke at 6 months and annually through 5 years.
Secondary endpoints: The following endpoints will be assessed at 1 month, 6 months, and annually through 5 years:
1. Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) event rates via Kaplan-Meier. MACCE is defined as a composite of:
¿ all-cause death
¿ myocardial infarction (MI)
¿ all stroke, and
¿ reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
2. The occurrence of individual MACCE components event rates via Kaplan-Meier
3. Major Adverse Events (MAE) event rates via Kaplan-Meier
4. Conduction disturbance requiring permanent pacemaker implantation event rates via Kaplan-Meier
5. Change in NYHA class
6. Quality of Life (QoL) change using the following measures:
¿ Kansas City Cardiomyopathy Questionnaire (KCCQ)
¿ SF 12, and
¿ EuroQoL7. Echocardiographic assessment of valve performance using the following measures:
¿ transvalvular mean gradient
¿ effective orifice area
¿ degree of aortic valve regurgitation (transvalvular and paravalvular)
8. Aortic valve disease hospitalization event rates via Kaplan-Meier
9. Cardiovascular deaths and valve-related deaths event rates viaKaplan-Meier
10. Strokes (of any severity) and TIAs event rates via Kaplan-Meier
11. Evidence of prosthetic valve dysfunction
|
| Follow-up Visits and Length of Follow-up |
Annually through 5 years
|
