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ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis (TALP-FIM)

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ClinicalTrials.gov Identifier: NCT02986737
Recruitment Status : Active, not recruiting
First Posted : December 8, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation ( Symetis SA )

Brief Summary:
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: ACURATE neo™ and ACURATE TA™ LP Not Applicable

Detailed Description:

This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention.

The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Medical device trial
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Actual Study Start Date : December 8, 2014
Actual Primary Completion Date : March 3, 2015
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACURATE neo™ and ACURATE TA™ LP
Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System
Device: ACURATE neo™ and ACURATE TA™ LP
ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]
    incidence of all cause mortality at 30 days

  2. Mean aortic gradient after device implantation [ Time Frame: 7 days or Discharge ]
    mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up


Secondary Outcome Measures :
  1. rate of clinical endpoints VARC II [ Time Frame: 30 days and month 12 ]
    rate of clinical endpoints VARC II at 30 days and 12 months

  2. procedural success [ Time Frame: procedure ]
    procedural success defined as ACURATE neo™ at intended location

  3. device success assessed according to composite VARC 2 criteria [ Time Frame: 7 days, 30 days, 12 months ]

    Device success defined as:

    • ACURATE neo™ implanted in intended location
    • No impingement of the mitral valve
    • Normal coronary blood flow
    • Insufficiency < Grade 3
    • Mean aortic gradient < 20mmHg
    • EOA ≥ 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant

  4. functional improvement from Baseline as per NYHA Functional Classification [ Time Frame: 30 days and 12 months follow up ]
    functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient 75 years of age and older
  2. Severe aortic stenosis defined as:

    Mean aortic gradient > 40mmHg or o Peak jet velocity > 4.0m/sor Aortic valve area of < 1.0cm2

  3. High risk candidate for conventional AVR defined as:

    STS score ≥ 10 or Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co- morbid conditions unrelated to aortic stenosis

  4. NYHA Functional Class > II
  5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route
  6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
  7. Patient willing to participate in the study and provides signed informed consent

Exclusion Criteria:

  1. Congenital unicuspid or bicuspid aortic valve
  2. Extreme eccentricity of calcification
  3. Severe mitral regurgitation (> Grade 2)
  4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
  5. LV apex is not accessible via transapical access due to severe chest deformity
  6. Previous surgery of the LV using a patch, such as the Dor procedure
  7. Presence of apical LV thrombus
  8. Calcified pericardium
  9. Septal hypertrophy unacceptable for transapical procedure
  10. Transesophageal echocardiogram (TEE) is contraindicated
  11. ECHO evidence of intracardiac mass, thrombus, or vegetation
  12. LVEF < 30% by ECHO
  13. Emergency procedure pre-implant including CAD requiring revascularization
  14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
  15. Acute myocardial infarction within 1 month prior to implant procedure
  16. Previous TIA or stroke within 3 months prior to implant procedure
  17. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure
  18. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
  19. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  20. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
  21. Primary hypertrophic obstructive cardiomyopathy (HOCM)
  22. Active infection, endocarditis or pyrexia
  23. Hepatic failure (> Child B)
  24. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
  25. Refusal of surgery
  26. Severe COPD requiring home oxygen
  27. Neurological disease severely affecting ambulation, daily functioning, or dementia
  28. Life expectancy < 12 months due to non-cardiac co-morbid conditions
  29. Contraindication to study medication, contrast media, or allergy to nitinol
  30. Currently participating in an investigational drug or another device study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986737


Locations
Germany
Kerckhoff-Klinik
Bad Nauheim, Germany, 61231
Klinik für Herz-und Gefäßchirurgie
Hamburg, Germany, 20246
Sponsors and Collaborators
Symetis SA
Investigators
Principal Investigator: Mirko Doss, Prof.Dr.Med Abteilung Herzchirurgie Kerckhoff-Klinik

Responsible Party: Symetis SA
ClinicalTrials.gov Identifier: NCT02986737     History of Changes
Other Study ID Numbers: 2014-02
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Scientific Corporation ( Symetis SA ):
TAVI
Aortic Stenosis
Transcatether Aortic Valve Implantation

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction