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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721642
• Other study ID #: CIP-DP1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 25, 2012
• Last updated: June 26, 2014
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2014
• Source: Apica Cardiovascular Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Apica Cardiovascular ASC Access, Stability and Closure Device
Access, stabilisation and closure of trans-apical approach for TAVI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apica Cardiovascular Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Access safety	Observation of no myocardial tearing on entry of the device	Within 2 hours from initial skin incision	Yes
Primary	Closure safety	Observation of no acute post-procedural bleeding or pericardial effusion.	Within 2 hours from initial skin incision	Yes
Secondary	Investigational device performance: LV function	% LVEF no worse than baseline as assessed by echocardiography	24 hours, 30 days and 90 days post-procedure	No