Aortic Valve Stenosis
Conditions
Keywords
access, closure, trans-apical, trans-catheter aortic valve implantation, TAVI, trans-catheter aortic valve repair, TAVR
Brief summary
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made post-procedure, at 30 days and 90 days as well as longer term follow-up.
Interventions
DEVICEApica Cardiovascular ASC Access, Stability and Closure Device
Access, stabilisation and closure of trans-apical approach for TAVI
Sponsors
Apica Cardiovascular Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject age ≥ 18 years of age. * Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. Subjects selected will meet all of the TAVI inclusion criteria as follows: * Subject has Senile degenerative aortic stenosis with echocardiography derived criteria: mean gradient \> 40 mm Hg or jet velocity \> 4.0 m/s or an aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2. * Subject is symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class \> II. * Additive EuroScore \> 9 * Aortic annulus diameter \> 21mm to \< 27mm by TEE * The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. * The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. * The subject, after formal consults by a cardiologist and two cardiovascular surgeons agreed that medical factors precluding operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeded the probability of meaningful improvement. Specifically the probability of death or serious, irreversible morbidity exceeded 50%.
Exclusion criteria
Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. The following TAVI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access safety | Within 2 hours from initial skin incision | Observation of no myocardial tearing on entry of the device |
| Closure safety | Within 2 hours from initial skin incision | Observation of no acute post-procedural bleeding or pericardial effusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigational device performance: LV function | 24 hours, 30 days and 90 days post-procedure | % LVEF no worse than baseline as assessed by echocardiography |
Outcome results
None listed