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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apica Cardiovascular Limited
ClinicalTrials.gov Identifier:
NCT01721642
First received: September 25, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Aortic Valve Stenosis
Device: Apica Cardiovascular ASC Access, Stability and Closure Device
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Apica Cardiovascular Limited:

Primary Outcome Measures:
  • Access safety [ Time Frame: Within 2 hours from initial skin incision ] [ Designated as safety issue: Yes ]
    Observation of no myocardial tearing on entry of the device

  • Closure safety [ Time Frame: Within 2 hours from initial skin incision ] [ Designated as safety issue: Yes ]
    Observation of no acute post-procedural bleeding or pericardial effusion.


Secondary Outcome Measures:
  • Investigational device performance: LV function [ Time Frame: 24 hours, 30 days and 90 days post-procedure ] [ Designated as safety issue: No ]
    % LVEF no worse than baseline as assessed by echocardiography


Enrollment: 31
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Apica Cardiovascular, ASC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721642

Sponsors and Collaborators
Apica Cardiovascular Limited
Investigators
Principal Investigator: Thomas Walther, Prof Kerckhoff-Klinik GmbH, Bad Nauheim, Germany
  More Information

No publications provided

Responsible Party: Apica Cardiovascular Limited
ClinicalTrials.gov Identifier: NCT01721642     History of Changes
Other Study ID Numbers: CIP-DP1
Study First Received: September 25, 2012
Last Updated: June 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Apica Cardiovascular Limited:
access
closure
trans-apical
trans-catheter aortic valve implantation
TAVI
trans-catheter aortic valve repair
TAVR

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 28, 2014