BIOVALVE - I / II Clincial Investigation

NCT02249000 | Completed DMC

• 1 other identifier: C1205
• Study Type: interventional
• Target: 68
• Locations: 4 countries
• Sites: 13

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

Conditions

Heart Valve Diseases; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Early safety at 30 days (Acc. to VARC-2)

  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)).

  30 days

Secondary Outcomes (3)

• Combined safety endpoint at 30 days (Acc. to VARC-1)

  30 days

• Clinical efficacy after 30 days (Acc. to VARC-2):

  30 days

• Echocardiograhic (ECHO) parameters

  Discharge, 30 days, 6 months, 12 months and annually through 5 years

Study Arms (1)

BIOVALVE prosthesis

EXPERIMENTAL

Transcatheter Aortic Valve Replacement (TAVR)

Device: BIOVALVE prosthesis

Interventions

BIOVALVE prosthesis DEVICE

Transcatheter Aortic Valve Replacement (TAVR)

BIOVALVE prosthesis

Eligibility Criteria

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

You may qualify if:

• The subject is ≥65 years
• The subject has provided written informed consent
• Subject is willing to participate in the clinical investigation and to comply with all of the study procedures and follow-up visits
• NHYA class ≥II
• 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
• 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)
• Annulus diameter as determined by multi-slice computed tomography (MSCT) from 23-26 mm

You may not qualify if:

• Trans-esophageal echocardiogram (TEE) is contraindicated
• Congenital bicuspid or unicuspid valve
• 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
• Transfemoral access vessel characteristics that would preclude safe placement of a 18 French sheath
• Vessel and/or anatomical characteristics that would preclude safe delivery of the BIOVALVE prosthesis to the ascending aorta and/or placement of the prosthesis
• 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
• Severe mitral regurgitation grade \>3
• Severe mitral stenosis
• Prosthetic mitral valve
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%
• Hemodynamic instability
• Percutaneous coronary intervention (PCI) within 30 days prior to index procedure and / or planned PCI during index procedure
• Renal insufficiency (creatinine \>2.5 mg/dl) or subject under dialysis and/or renal replacement therapy
• Any cerebrovascular event or transient ischemic attack (TIA) within 180 days prior to TAVI procedure
• 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)

Sponsors & Collaborators

• Biotronik AG: lead
• Medstar Health Research Institute: collaborator

Study Sites (13)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Städtische Kliniken Neuss - Lukaskrankenhaus

Neuss, North Rhine-Westphalia, 41464, Germany

Location

Segeberger Kliniken

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

Vivantes Klinikum

Berlin, 10249, Germany

Location

German Heart Center

Berlin, 13353, Germany

Location

University Heart Center

Cologne, 50937, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

University Heart Center

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Catharina-Ziekenhuis

Eindhoven, 5623, Netherlands

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 23022744 BACKGROUND

• 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.

  PMID: 21216553 BACKGROUND

• 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.

  PMID: 25983028 RESULT

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hendrik Treede, MD

  Universitätsklinikum Halle (Saale), Germany

  STUDY CHAIR

• Ulrich Schaefer, MD

  University Heart Center Hamburg, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2023
• Last Updated: June 11, 2024

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); BE (1); NL (1); DE (10)