MISSION-Registry: Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve Systyem in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry.
- Conditions
- aortic valve stenosisheart valve restriction1004697310007593
- Registration Number
- NL-OMON45758
- Lead Sponsor
- Edwards Lifesciences SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subject is 18 years or older
2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
4. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
5. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
1. Subject is diagnosed with pure aortic insufficiency.
2. Subject requires multiple valve replacement/repair
3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
4. Subject has severe ventricular dysfunction defined as LVEF < 25%.
5. Subject has a history of active endocarditis and/or myocarditis * 3 months before the intended treatment/scheduled surgery.
6. Subject has had an acute MI * 3 months before the intended treatment.
7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
8. Subject is oxygen or ventilator dependent.
9. Subject has life expectancy < 12 months.
10. Female subject is pregnant or lactating.
11. Subject with documented leukopenia (WBC < 3.5x 103/*L), acute anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.
12. Subject has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 1 month of procedure.
13. Subject has documented echocardiographic evidence of intracardiac mass, thrombus or vegetation.
14. Subject has renal insufficiency as determined by Serum creatinine * 200 *mol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
15. Subject with documented hyperparathyroidism.
16. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
17. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
18. Aneurysm of the aortic root and/or ascending aorta;Intra-operative exclusion criteria:
1. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)
2. Subject has calcium on the anterior mitral leaflet which cannot be removed.
3. Subject has extensive calcification of the aortic root.
4. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
5. The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
6. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).
7. The device is not available in the correct size for the subject.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Aortic Cross Clamp time</p><br>
- Secondary Outcome Measures
Name Time Method