BIOVALVE - I / II Clincial Investigation

NCT ID: NCT02249000

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2023-05-31

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.

Conditions

Heart Valve Diseases; Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIOVALVE prosthesis

Transcatheter Aortic Valve Replacement (TAVR)

Group Type: EXPERIMENTAL

BIOVALVE prosthesis

Intervention Type: DEVICE

Transcatheter Aortic Valve Replacement (TAVR)

Interventions

BIOVALVE prosthesis

Transcatheter Aortic Valve Replacement (TAVR)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hendrik Treede, MD

Role: STUDY_CHAIR

Universitätsklinikum Halle (Saale), Germany

Ulrich Schaefer, MD

Role: STUDY_CHAIR

University Heart Center Hamburg, Germany

Locations

ZNA Middelheim

Antwerp, , Belgium

Städtische Kliniken Neuss - Lukaskrankenhaus

Neuss, North Rhine-Westphalia, Germany

Segeberger Kliniken

Bad Segeberg, Schleswig-Holstein, Germany

Vivantes Klinikum

Berlin, , Germany

German Heart Center

Berlin, , Germany

University Heart Center

Cologne, , Germany

Universitätsklinikum Halle (Saale)

Halle, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

University Heart Center

Hamburg, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

Catharina-Ziekenhuis

Eindhoven, , Netherlands

Universitätsspital Zürich

Zurich, , Switzerland

Countries

Belgium; Germany; Netherlands; Switzerland

References

Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.

Reference Type: BACKGROUND

PMID: 23022744 (View on PubMed)

Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7.

Reference Type: BACKGROUND

PMID: 21216553 (View on PubMed)

Treede H, Lubos E, Conradi L, Deuschl F, Asch FM, Weissman NJ, Schofer N, Schirmer J, Koschyk D, Blankenberg S, Reichenspurner H, Schaefer U. Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve. EuroIntervention. 2015 Nov;11(7):785-92. doi: 10.4244/EIJY15M05_05.

Reference Type: RESULT

PMID: 25983028 (View on PubMed)

Other Identifiers

C1205

Identifier Type: -

Identifier Source: org_study_id