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BIOVALVE - I / II Clincial Investigation (BIOVALVE)

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ClinicalTrials.gov Identifier: NCT02249000
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : February 16, 2017
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve implantation

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Aortic Valve Stenosis Device: BIOVALVE prosthesis Not Applicable

Detailed Description:

In a non-randomized, prospective, multi-center clinical investigation, approximately 86 eligible subjects will be enrolled.

Phase 1: BIOVALVE-I feasibility clinical investigation: Approximately 13 eligible subjects will be enrolled.

Phase 2: BIOVALVE-II pilot clinical investigation: Approximately 73 eligible subjects will be enrolled.

BIOVALVE-I/II subjects follow the same clinical investigation plan (CIP) in all aspects.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Clinical Performance of the Self-expanding Transcatheter BIOVALVE Prosthesis in Subjects With Severe Symptomatic Aortic Stenosis Suitable for Transfemoral Transcatheter Aortic Valve Implantation
Study Start Date : September 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIOVALVE prosthesis
Transcatheter Aortic Valve Replacement (TAVR)
Device: BIOVALVE prosthesis
Transcatheter Aortic Valve Replacement (TAVR)




Primary Outcome Measures :
  1. Early safety at 30 days (Acc. to VARC-2) [ Time Frame: 30 days ]
    A composite of all-cause mortality, all stroke (disabling/non-disabling), life-threatening bleeding, acute kidney injury stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiring intervention, major vascular complication and valve-related dysfunction requiring repeat procedure (balloon aortic valvuloplasty (BAV), transcatheter aortic valve implantation (TAVI), or surgical aortic valve replacement (SAVR)).


Secondary Outcome Measures :
  1. Combined safety endpoint at 30 days (Acc. to VARC-1) [ Time Frame: 30 days ]
    A composite of all-cause mortality, major stroke, life-threatening (or disabling) bleeding, acute kidney injury stage 3 (including renal replacement therapy), peri-procedural myocardial infarction, major vascular complication and repeat procedure for valve-related dysfunction (surgical or interventional therapy)

  2. Clinical efficacy after 30 days (Acc. to VARC-2): [ Time Frame: 30 days ]

    A composite of all-cause mortality, all stroke (disabling and non-disabling), requiring hospitalizations for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve-related dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area (EOA) ≤0.9-1.1 cm2 * and/or Doppler velocity index (DVI) <0.35 m/s, and/or moderate or severe prosthetic valve regurgitation **).

    * depending on body surface area

    ** refers to VARC-2 definitions


  3. Echocardiograhic (ECHO) parameters [ Time Frame: Discharge, 30 days, 6 months, 12 months and annually through 5 years ]
    Effective orifice area (EOA) and effective orifice area index (EOAI) Mean prosthetic valve gradient Prosthetic valve regurgitation (Acc. to VARC-1 and VARC-2)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is ≥65 years
  2. The subject has provided written informed consent
  3. Subject is willing to participate in the clinical investigation and to comply with all of the study procedures and follow-up visits
  4. NHYA class ≥II
  5. High surgical risk: Logistic EuroSCORE-I ≥20% (or equivalence of EuroSCORE-II) or STS score ≥10% or co-morbidity judged by the heart team (consisting of at least one interventional cardiologist and one cardiac surgeon) to pose an absolute or relative contraindication for conventional aortic valve replacement according to VARC-2
  6. Severe symptomatic calcific aortic valve stenosis characterized by mean aortic gradient >40 mm Hg or peak jet velocity >4.0 m/s or effective orifice area (EOA) of <1.0 cm2 (<0.6 cm2/m2 body surface area)
  7. Annulus diameter as determined by multi-slice computed tomography (MSCT) from 23-26 mm

Exclusion Criteria:

  1. Trans-esophageal echocardiogram (TEE) is contraindicated
  2. Congenital bicuspid or unicuspid valve
  3. Left ventricular outflow tract (LVOT) obstruction such as hypertrophic obstructive cardio myopathy (HOCM) or subject presenting with systolic anterior motion (SAM). Evidence of intra cardiac mass, thrombus or vegetation
  4. Transfemoral access vessel characteristics that would preclude safe placement of a 18 French sheath
  5. Vessel and/or anatomical characteristics that would preclude safe delivery of the BIOVALVE prosthesis to the ascending aorta and/or placement of the prosthesis
  6. Anatomical restrictions such as shallow sinuses with heavily calcified leaflets, low height of coronary ostia, extreme tortuosity of the aortic arch, thoracic (TAA) or abdominal (AAA) aortic aneurysm, presence of endovascular stent graft
  7. Severe mitral regurgitation grade >3
  8. Severe mitral stenosis
  9. Prosthetic mitral valve
  10. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%
  11. Hemodynamic instability
  12. Percutaneous coronary intervention (PCI) within 30 days prior to index procedure and / or planned PCI during index procedure
  13. Renal insufficiency (creatinine >2.5 mg/dl) or subject under dialysis and/or renal replacement therapy
  14. Any cerebrovascular event or transient ischemic attack (TIA) within 180 days prior to TAVI procedure
  15. Evidence of acute myocardial infarction (defined as ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within ≤30 days prior to TAVI procedure)
  16. Blood dyscrasia defined as: leucopenia (WBC <1000 mm³), thrombocytopenia (platelet count <50'000 cells/mm³), history of bleeding diathesis requiring blood transfusion
  17. Ongoing sepsis or suspected active endocarditis
  18. Active peptic ulcer or gastrointestinal bleeding within last 3 months that would preclude anticoagulation
  19. Subject refuses blood transfusion
  20. Known hypersensitivity to, or contraindication to nitinol, anticoagulation/antiplatelet regimes, any other medications required for the procedure or post-procedure as determined by the heart team, or sensitivity to contrast media which cannot be adequately pre-medicated
  21. Need for emergency TAVI intervention, or other medical, social, or psychological conditions that in the opinion of the heart team precludes the subjects from appropriate consent or adherence to protocol required follow-up exams
  22. Expectation that subject will not improve despite treatment of aortic stenosis
  23. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbidities
  24. Severe pulmonary hypertension (> 60 mm Hg assessed by continuous wave Doppler, TTE) or clinical signs of acute severe right ventricular dysfunction
  25. Currently participating in another investigational drug or device study where primary endpoint has not been reached yet

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): NCT02249000


Contacts
Contact: Karin Lussi +41448645435 karin.lussi@biotronik.com
Contact: Myriam Stieler + 41448645517 myriam.stieler@biotronik.com

Locations
Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium, 2020
Contact: Stefan Verheye, MD    +3232803255    stefan.verheye@gmail.com   
Contact: Paul Vermeersch    +3232803255    paul.vermeersch@zna.be   
Germany
Städtische Kliniken Neuss - Lukaskrankenhaus Recruiting
Neuss, Nordrhein-Westfalen, Germany, 41464
Contact: Michael Haude, MD    +49 21 31 888 2001    mhaude@lukasneuss.de   
Contact: Hubertus Degen, MD    +49 21 31 888 2001    hdegen@lukasneuss.de   
Segeberger Kliniken Recruiting
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Contact: Mohamed Abdel-Wahab, MD    +49 45 51 80 24 801    mohamed.abdel-wahab@segebergerkliniken.de   
Contact: Gert Richardt, MD    +49 45 51 80 24 801    gert.richardt@segebergerkliniken.de   
Sub-Investigator: Bettina Schwarz, MD         
Sub-Investigator: Mohamed El-Mawardy, MD         
Vivantes Klinikum Recruiting
Berlin, Germany, 10249
Contact: Stephan Kische, MD    +49 30 130 23 1997    stephan.kische@vivantes.de   
Contact: Hüseyin Ince, MD    +49 30 130 23 1997    hueseyin.ince@vivantes.de   
German Heart Center Recruiting
Berlin, Germany, 13353
Contact: Volkmar Falk, MD    + 49 30 4593 2000    falk@dhzb.de   
Contact: Jörg Kempfert, MD    +49 30 4593 2084    kempfert@dhzb.de   
Universitätsklinikum Halle (Saale) Recruiting
Halle, Germany, 06120
Contact: Hendrik Treede, MD    +493455572719    Hendrik.Treede@UK-Halle.de   
Contact: Stefan Frantz, MD    +493455572601    stefan.frantz@uk-halle.de   
Sub-Investigator: Efstratios Charitos, MD         
Sub-Investigator: Ulrich Hofmann, MD         
Sub-Investigator: Jochen Schröder, MD         
Sub-Investigator: Miriam Silaschi, MD         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Christian Frerker, MD    +49401818854429    c.frerker@asklepios.com   
Contact: Karl-Heinz Kuck, MD    +49401818852305    k.kuck@asklepios.com   
Sub-Investigator: Tobias Schmidt, MD         
University Heart Center Recruiting
Hamburg, Germany, 20246
Contact: Ulrich Schaefer, MD    +4940741053979    u.schaefer@uke.de   
Contact: Lenard Conradi, MD    +4940741053440    lconradi@uke.de   
University Heart Center Recruiting
Köln, Germany, 50937
Contact: Stephan Baldus, MD    + 49 221 478 32511    stephan.baldus@uk-koeln.de   
Contact: Thorsten Wahlers, MD    +49 221 478-325 08    thorsten.wahlers@uk-koeln.de   
Sub-Investigator: Tanja Rudolph, MD         
Sub-Investigator: Volker Rudolf, MD         
Sub-Investigator: Navid Mader, MD         
Sub-Investigator: Maximilian Scherner, MD         
Sub-Investigator: Elmar Kuhn, MD         
Herzzentrum Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Axel Linke, MD    +493418651426    Axel.Linke@medizin.uni-leipzig.de   
Contact: David Holzhey, MD    +493418651421    dholzhey@web.de   
Sub-Investigator: Norman Mangner, MD         
Universitätsmedizin Rostock Recruiting
Rostock, Germany, 18057
Contact: Hueseyin Ince, MD    +493814947701    hueseyin.ince@med.uni-rostock.de   
Contact: Mohammad Sherif, MD    +493814947795    mohammad.sherif@med.uni-rostock.de   
Sub-Investigator: Alper Oener, MD         
Netherlands
Catharina-Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623
Contact: W.A.L Tonino, MD    +31402397004    pim.tonino@cze.nl   
Contact: B.R.G. Brueren, MD       guus.brueren@catharinaziekenhuis.nl   
Switzerland
Universitätsspital Zürich Recruiting
Zurich, Switzerland, 8091
Contact: Francesco Maisano, MD    +41442553298    francesco.maisano@usz.ch   
Contact: Fabian Nietlispach, MD    +41442558599    Fabian.Nietlispach@usz.ch   
Sub-Investigator: Maurizio Taramasso, MD         
Sponsors and Collaborators
Biotronik AG
Medstar Health Research Institute
Investigators
Study Chair: Hendrik Treede, MD Universitätsklinikum Halle (Saale), Germany
Study Chair: Ulrich Schaefer, MD University Heart Center Hamburg, Germany

Publications of Results:
Other Publications:
Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT02249000     History of Changes
Other Study ID Numbers: C1205
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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