Calcified pure or predominant aortic valve stenosis narrowed aortic valve
Conditions
Interventions
All patients should be intubated and procedures should be performed
under general anesthesia. After delineation of the cardiac apex using
echocardiography, the cardiac apex should be exposed using a
Sponsors
Micro Interventional Devices Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age *18 years 2. Patient is undergoing a transapical aortic valve replacement with an Edwards Lifesciences Sapien XT valve and Ascendra Plus transapical delivery system or an Edwards Sapien 3 valve and Certitude transapical delivery system via a surgical approach 3. Targeted transapical access site having a myocardial wall thickness * 10mm 4. Able and willing to comply with all study requirements, including the required study follow-up visits 5. Able and willing to give consent and follow study instructions 6. Patient has a calcified pure or predominant AS and a valve diameter of between 18 mm and 29 mm and is inoperable OR 7. Patient has a calcified pure or predominant AS and a valve diameter of between 18 mm and 29 mm and is older than 75 years and has a STS score >4 and 20 and
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing 2. Active systemic infection 3. Pericardial infection 4. Targeted transapical access site that has been compromised due to anterior-wall myocardial infarction 5. Ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of pulsatile bleeding requiring significant surgical intervention (more than one pledgeted suture) at discharge and at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Treatment parameters that will include procedure time and any reported assessment of ease of use of the Permaseal device. - New hypo or akinesia at the apex during follow-up period of 90 days and 12 months. | — |
Countries
Netherlands
Outcome results
None listed