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

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

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