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

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

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 Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Apica Cardiovascular ASC Access, Stability and Closure Device

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apica Cardiovascular ASC Device; Access, stabilisation and closure with the Apica Cardiovascular ASC Device	Device: Apica Cardiovascular ASC Access, Stability and Closure Device; Access, stabilisation and closure of trans-apical approach for TAVI; Other Names: Apica Cardiovascular, ASC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access safety	Observation of no myocardial tearing on entry of the device	Within 2 hours from initial skin incision
Closure safety	Observation of no acute post-procedural bleeding or pericardial effusion.	Within 2 hours from initial skin incision

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Apica Cardiovascular Limited
• Investigators: Principal Investigator: Thomas Walther, Prof, Kerckhoff Klinik

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: November 2, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: closure; TAVI; TAVR; access; trans-apical; trans-catheter aortic valve implantation; trans-catheter aortic valve repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CIP-DP1