Clinical trial NCT01721642: A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
Official title: A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device During and After Transcatheter Aortic Valve Implantation (TAVI) Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aortic Valve Stenosis
Keywords: access
closure
trans-apical
trans-catheter aortic valve implantation
TAVI
trans-catheter aortic valve repair
TAVR
Lead sponsor: Apica Cardiovascular Limited
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria shall apply:

* Evidence of an acute myocardial infarction \< 1 month before the intended treatment
* Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
* Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \> 3+)
* Pre-existing prosthetic heart valve in an position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
* Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
* Untreated clinically significant coronary artery disease requiring revascularization
* Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
* Need for emergency surgery for any reason
* Hypertrophic cardiomyopathy with or without obstruction
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
* A known hypersensitivity of contraindication to asprin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated
* Recent (within 6 months) cerebrovascular accident or transient ischemic attack
* Renal insufficiency and/or end stage renal disease requiring chronic dialysis.
* Life expectancy \< 12 months due to non-cardiac co-morbid conditions.

The following ASC device exclusion criteria shall apply:

* Subjects with \<10mm Left ventricular wall thickness at apical access site
* LVEF \< 30%
* Subject with previous DOR procedure
* Subject access site has less than 2 cm squared "fat" free area under visual observation
* Subject has known Allergy or hypersensitivity to Titanium
* Subject requires MR Imaging post procedure
* Subject is Pregnant

Primary outcomes:
measure: Access safety
timeFrame: Within 2 hours from initial skin incision
measure: Closure safety
timeFrame: Within 2 hours from initial skin incision
Secondary outcomes:
measure: Investigational device performance: LV function
timeFrame: 24 hours, 30 days and 90 days post-procedure
Other outcomes:
Locations:
Study officials:
affiliation: Kerckhoff Klinik
name: Thomas Walther, Prof
role: PRINCIPAL_INVESTIGATOR
References: