Brief Title
BIOVALVE - I / II Clincial Investigation
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
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
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
Primary Outcome
Early safety at 30 days (Acc. to VARC-2)
Secondary Outcome
Combined safety endpoint at 30 days (Acc. to VARC-1)
Condition
Heart Valve Diseases
Intervention
BIOVALVE prosthesis
Study Arms / Comparison Groups
BIOVALVE prosthesis
Description: Transcatheter Aortic Valve Replacement (TAVR)
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
86
Start Date
September 2014
Completion Date
December 2022
Primary Completion Date
March 2018
Eligibility 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
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hendrik Treede, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02249000
Organization ID
C1205
Responsible Party
Sponsor
Study Sponsor
Biotronik AG
Collaborators
Medstar Health Research Institute
Study Sponsor
Hendrik Treede, MD, Study Chair, Universitätsklinikum Halle (Saale), Germany
Verification Date
January 2019