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

Phase 1

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Apica Cardiovascular ASC Access, Stability and Closure Device

• Registration Number: NCT01721642
• Lead Sponsor: Apica Cardiovascular Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apica Cardiovascular ASC Device	Apica Cardiovascular ASC Access, Stability and Closure Device	Access, stabilisation and closure with the Apica Cardiovascular ASC Device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Investigational device performance: LV function	24 hours, 30 days and 90 days post-procedure	% LVEF no worse than baseline as assessed by echocardiography