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

NCT01721642 | Completed Phase 1 DMC

• 1 other identifier: CIP-DP1
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Stenosis

Keywords

access; closure; trans-apical; trans-catheter aortic valve implantation; TAVI; trans-catheter aortic valve repair; TAVR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Investigational device performance: LV function

  24 hours, 30 days and 90 days post-procedure

Study Arms (1)

Apica Cardiovascular ASC Device

EXPERIMENTAL

Access, stabilisation and closure with the Apica Cardiovascular ASC Device

Device: Apica Cardiovascular ASC Access, Stability and Closure Device

Interventions

Apica Cardiovascular ASC Access, Stability and Closure Device DEVICE

Access, stabilisation and closure of trans-apical approach for TAVI

Also known as: Apica Cardiovascular, ASC

Apica Cardiovascular ASC Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age ≥ 18 years of age.
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apica Cardiovascular Limited: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Thomas Walther, Prof

  Kerckhoff Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: November 6, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 27, 2014

Record last verified: 2014-06