Heart Valve DiseasesBIOVALVENCT02249000
BIOVALVE - I / II Clincial Investigation
A study testing BIOVALVE prosthesis in people with Heart Valve Diseases and Aortic Valve Stenosis, run by Biotronik AG at 13 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Valve Diseases, Aortic Valve Stenosis
- What is being tested?
- BIOVALVE prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Sep 2014to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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)
- Blood dyscrasia defined as: leucopenia (WBC <1000 mm³), thrombocytopenia (platelet count <50'000 cells/mm³), history of bleeding diathesis requiring blood transfusion
- Ongoing sepsis or suspected active endocarditis
- Active peptic ulcer or gastrointestinal bleeding within last 3 months that would preclude anticoagulation
- Subject refuses blood transfusion
- 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
- 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
- Expectation that subject will not improve despite treatment of aortic stenosis
- Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbidities
- Severe pulmonary hypertension (> 60 mm Hg assessed by continuous wave Doppler, TTE) or clinical signs of acute severe right ventricular dysfunction
- Currently participating in another investigational drug or device study where primary endpoint has not been reached yet
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Germany10 sites
Segeberger Kliniken
Bad Segeberg, Schleswig-Holstein, 23795
Vivantes Klinikum
Berlin, 10249
German Heart Center
Berlin, 13353
University Heart Center
Cologne, 50937
Universitätsklinikum Halle (Saale)
Halle, 06120
Asklepios Klinik St. Georg
Hamburg, 20099
University Heart Center
Hamburg, 20246
Herzzentrum Leipzig
Leipzig, 04289
Städtische Kliniken Neuss - Lukaskrankenhaus
Neuss, North Rhine-Westphalia, 41464
Universitätsmedizin Rostock
Rostock, 18057
About this study
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
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
Read the 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
- Being tested
- BIOVALVE prosthesis
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOVALVE prosthesisDevice
Transcatheter Aortic Valve Replacement (TAVR)
| Study group | Role | What they receive |
|---|---|---|
| BIOVALVE prosthesis | Experimental | Transcatheter Aortic Valve Replacement (TAVR) Receives: Device: BIOVALVE prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 30 days
Secondary outcomes (3)
Combined safety endpoint at 30 days (Acc. to VARC-1)
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)
Measured: 30 days
Clinical efficacy after 30 days (Acc. to VARC-2):
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
Measured: 30 days
Echocardiograhic (ECHO) parameters
Effective orifice area (EOA) and effective orifice area index (EOAI) Mean prosthetic valve gradient Prosthetic valve regurgitation (Acc. to VARC-1 and VARC-2)
Measured: Discharge, 30 days, 6 months, 12 months and annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2018
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Hendrik Treede, MD, Study chair, Universitätsklinikum Halle (Saale), GermanyUlrich Schaefer, MD, Study chair, University Heart Center Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249000
- Sponsor's protocol ID
- C1205
- Acronym
- BIOVALVE
- Status last verified
- Jan 2019
- First submitted
- 23 Sep 2014
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23022744Leon 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.
PubMed 21216553Treede 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.
PubMed 25983028
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02249000
- Acronym / sponsor ID
- BIOVALVE / C1205
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Study start
- Sep 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOVALVE prosthesis | Experimental | Device: BIOVALVE prosthesisTranscatheter Aortic Valve Replacement (TAVR) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOVALVE prosthesisTranscatheter Aortic Valve Replacement (TAVR) | Device | BIOVALVE prosthesis |
Primary outcome
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)).
3 secondary outcomes
Combined safety endpoint at 30 days (Acc. to VARC-1)
Time frame: 30 days
Clinical efficacy after 30 days (Acc. to VARC-2):
Time frame: 30 days
Echocardiograhic (ECHO) parameters
Time frame: Discharge, 30 days, 6 months, 12 months and annually through 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 23022744Kappetein 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.
- Background: PubMed 21216553Leon 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.
- Results publication: PubMed 25983028Treede 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Treede, MD study chair
Universitätsklinikum Halle (Saale), Germany
Ulrich Schaefer, MD study chair
University Heart Center Hamburg, Germany
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOVALVE prosthesis in people with Heart Valve Diseases and Aortic Valve Stenosis, run by Biotronik AG at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Belgium, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early safety at 30 days (Acc. to VARC-2) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249000, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.