A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device

NCT ID: NCT01721642

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apica Cardiovascular ASC Device

Access, stabilisation and closure with the Apica Cardiovascular ASC Device

Group Type: EXPERIMENTAL

Apica Cardiovascular ASC Access, Stability and Closure Device

Intervention Type: DEVICE

Access, stabilisation and closure of trans-apical approach for TAVI

Interventions

Apica Cardiovascular ASC Access, Stability and Closure Device

Access, stabilisation and closure of trans-apical approach for TAVI

Intervention Type: DEVICE

Other Intervention Names

Apica Cardiovascular, ASC

Eligibility Criteria

Inclusion Criteria

• Subject age ≥ 18 years of age.

• 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

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apica Cardiovascular Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Walther, Prof

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Klinik

Other Identifiers

CIP-DP1

Identifier Type: -

Identifier Source: org_study_id