Aortic Valve StenosisCP-0001NCT02818959
First in Man Study of the JenaValve TAVI Plus System Transfemoral
A study testing JenaValve Pericardial TAVR System in people with Aortic Valve Stenosis and Heart Valve Diseases, run by JenaValve Technology, Inc. at 2 sites in Germany.
Trial summary
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases
- What is being tested?
- JenaValve Pericardial TAVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2013to May 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosed with severe native aortic valve stenosis
- NYHA functional class II or higher
- Increased risk for surgical aortic valve replacement
- Comply with post-operative follow-up visits and requirements
Who cannot join
- Combined aortic valve disease with severe aortic insufficiency
- Presence of moderate mitral insufficiency or previous mitral prosthesis
- Severe pulmonary hypertension
- Congenital uni- or bicuspid aortic valve
- Endocarditis or active infection
- Life expectancy < 12 months
- Need for emergency surgery for any reason
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Koln Medical Center
Cologne, 50937
University of Hamburg Medical Center
Hamburg, 20251
About this study
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
Read the detailed description
The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.
- Being tested
- JenaValve Pericardial TAVR System
- Keywords
- Aortic Valve Disease, Aortic Valve Replacement, Transcatheter, Transfemoral, Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JenaValve Pericardial TAVR SystemDevice
The JenaValve Pericardial TAVI system is intended for use in subjects with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement | Experimental | In this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended for use in subjects with severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using a delivery system. Receives: Device: JenaValve Pericardial TAVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve Plus Prosthesis irrespective of the underlying cause of death.
Measured: 30 days
Secondary outcomes (1)
Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints
- Myocardial Infarction
- Stroke
- Major Bleeding
- Acute Kidney Injury
- Vascular Complications
- Conduction Disturbances and Arrhythmias
- TAVR-related Complications
Measured: Index Procedure and Immediate Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMay 2015
Why it stopped: Due to inability to recruit sufficient sample size in reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- JenaValve Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Baldus, MD, Principal investigator, University of Koln Medical CenterHendrik Treede, MD, Principal investigator, University of Hamburg Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818959
- Sponsor's protocol ID
- JV04FIM
- Acronym
- CP-0001
- Status last verified
- May 2020
- First submitted
- 24 Jun 2016
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Man Study of the JenaValve TAVI Plus System Transfemoral
- ClinicalTrials.gov ID
- NCT02818959
- Acronym / sponsor ID
- CP-0001 / JV04FIM
- Keywords
- Aortic Valve Disease, Aortic Valve Replacement, Transcatheter, Transfemoral, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to inability to recruit sufficient sample size in reasonable time frame.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- JenaValve Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jun 2016 (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.
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
Detailed description
The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement | Experimental | Device: JenaValve Pericardial TAVR SystemIn this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended for use in subjects with severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using a delivery system. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Diagnosed with severe native aortic valve stenosis
- NYHA functional class II or higher
- Increased risk for surgical aortic valve replacement
- Comply with post-operative follow-up visits and requirements
Key exclusion criteria (7 listed)
- Combined aortic valve disease with severe aortic insufficiency
- Presence of moderate mitral insufficiency or previous mitral prosthesis
- Severe pulmonary hypertension
- Congenital uni- or bicuspid aortic valve
- Endocarditis or active infection
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 |
|---|---|---|
| JenaValve Pericardial TAVR SystemThe JenaValve Pericardial TAVI system is intended for use in subjects with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement. | Device | Transcatheter Aortic Valve Replacement |
Primary outcome
All-Cause Mortality
Time frame: 30 days
30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve Plus Prosthesis irrespective of the underlying cause of death.
1 secondary outcome
Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints
Time frame: Index Procedure and Immediate Post-operative
Results and safety
The study was stopped early (reason given: Due to inability to recruit sufficient sample size in reasonable time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Stephan Baldus, MD principal investigator
University of Koln Medical Center
Hendrik Treede, MD principal investigator
University of Hamburg Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JenaValve Pericardial TAVR System in people with Aortic Valve Stenosis and Heart Valve Diseases, run by JenaValve Technology, Inc. at 2 sites in Germany.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 was stopped early (reason given: Due to inability to recruit sufficient sample size in reasonable time frame.). Results are not available in the source record.
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?
All-Cause Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2020.