Brief Title
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
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Access safety
Secondary Outcome
Investigational device performance: LV function
Condition
Aortic Valve Stenosis
Intervention
Apica Cardiovascular ASC Access, Stability and Closure Device
Study Arms / Comparison Groups
Apica Cardiovascular ASC Device
Description: Access, stabilisation and closure with the Apica Cardiovascular ASC Device
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
31
Start Date
May 2012
Completion Date
March 2013
Primary Completion Date
January 2013
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Walther, Prof, ,
Administrative Informations
NCT ID
NCT01721642
Organization ID
CIP-DP1
Responsible Party
Sponsor
Study Sponsor
Apica Cardiovascular Limited
Study Sponsor
Thomas Walther, Prof, Principal Investigator, Kerckhoff Klinik
Verification Date
June 2014