Aortic Valve StenosisTrue™FlowNCT02847546
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
An observational study of Aortic Valve Stenosis, run by C. R. Bard at 1 site in Germany.
Trial summary
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic Valve Implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- True™ Flow Valvuloplasty Perfusion Catheter
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Oct 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be males or non-pregnant females, at least 18 years of age.
Who may be able to join
- The subject voluntarily provides written informed consent prior to the collection of study-specific data or performance of study-specific procedures using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) for the site.
- The subject is a male or non-pregnant female ≥ 18 years old.
- The subject is undergoing TAVI for treatment of aortic stenosis.
- The subject has an annulus diameter that can be treated with the available size device, in accordance with the Instructions For Use (IFU).
Who cannot join
- The patient is unable or unwilling to provide written informed consent.
- The patient has a known allergy or sensitivity to contrast media that cannot be adequately pre-medicated.
- The patient has had previous aortic valve replacement.
- The patient has a known congenital aortic valve abnormality (e.g., bicuspid aortic valve).
- The patient has echocardiographic evidence of intracardiac mass, or thrombus.
- The patient has vascular conditions that make insertion and endovascular access to the aortic valve impossible.
- The patient has another medical condition, which, in the opinion of the Investigator, may cause him/her to confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures.
- The subject is currently participating in an investigational drug, biologic, or another device study that has not completed the study treatment or that clinically interferes with the objectives of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic Valve Implantation (TAVI).
Read the detailed description
The BARD® True™ Flow Valvuloplasty Perfusion Catheter Study is a prospective, single-center, non-randomized, single-arm observational study intended to collect data to confirm the performance and safety of the BARD® True™ Flow Valvuloplasty Perfusion Catheter (True™ Flow catheter) when used for dilatation of the aortic valve in preparation for Transcatheter Aortic Valve Implantation (TAVI). This study will be conducted in conformance with the Declaration of Helsinki, applicable national privacy laws, and European, national regulations and International Organization for Standardization (ISO) requirements (ISO 14155:2011 (E)).
- Conditions
- Aortic Valve Stenosis
- Being tested
- True™ Flow Valvuloplasty Perfusion Catheter
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True™ Flow Valvuloplasty Perfusion CatheterDevice
Balloon Aortic Valvuloplasty as preparation step in implantation of a Tanscatheter Aortic Valve Implantation (TAVI).
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful dilatation of the aortic valve using the True™ Flow Valvuloplasty Perfusion Catheter.
Defined as complete opening of the True™ Flow Valvuloplasty Perfusion Catheter by visual estimate and the ability of the inflated True™ Flow Valvuloplasty Perfusion balloon to stay stationary with clinically acceptable intraventricular pressure under rapid pacing, reduced pacing, or without pacing.
Measured: Duration of Dilatation of Balloon during Procedure (<120 minutes)
Freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure.
Defined as the time the study device catheter is introduced until the time TAVI device system is introduced.
Measured: Duration of Dilatation of Balloon during Procedure (<120 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionOct 2016
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.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Linke, Prof.Dr.med., Principal investigator, Helios Health Institute GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847546
- Sponsor's protocol ID
- BPV-14-004
- Acronym
- True™Flow
- Status last verified
- Jan 2017
- First submitted
- 18 Jul 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
- ClinicalTrials.gov ID
- NCT02847546
- Acronym / sponsor ID
- True™Flow / BPV-14-004
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Jul 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 primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic Valve Implantation (TAVI).
Detailed description
The BARD® True™ Flow Valvuloplasty Perfusion Catheter Study is a prospective, single-center, non-randomized, single-arm observational study intended to collect data to confirm the performance and safety of the BARD® True™ Flow Valvuloplasty Perfusion Catheter (True™ Flow catheter) when used for dilatation of the aortic valve in preparation for Transcatheter Aortic Valve Implantation (TAVI). This study will be conducted in conformance with the Declaration of Helsinki, applicable national privacy laws, and European, national regulations and International Organization for Standardization (ISO) requirements (ISO 14155:2011 (E)).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be males or non-pregnant females, at least 18 years of age.
Key inclusion criteria (4 listed)
- The subject voluntarily provides written informed consent prior to the collection of study-specific data or performance of study-specific procedures using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) for the site.
- The subject is a male or non-pregnant female ≥ 18 years old.
- The subject is undergoing TAVI for treatment of aortic stenosis.
- The subject has an annulus diameter that can be treated with the available size device, in accordance with the Instructions For Use (IFU).
Key exclusion criteria (8 listed)
- The patient is unable or unwilling to provide written informed consent.
- The patient has a known allergy or sensitivity to contrast media that cannot be adequately pre-medicated.
- The patient has had previous aortic valve replacement.
- The patient has a known congenital aortic valve abnormality (e.g., bicuspid aortic valve).
- The patient has echocardiographic evidence of intracardiac mass, or thrombus.
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 |
|---|---|---|
| True™ Flow Valvuloplasty Perfusion CatheterBalloon Aortic Valvuloplasty as preparation step in implantation of a Tanscatheter Aortic Valve Implantation (TAVI). | Device | – |
Primary outcome
Successful dilatation of the aortic valve using the True™ Flow Valvuloplasty Perfusion Catheter.
Time frame: Duration of Dilatation of Balloon during Procedure (<120 minutes)
Defined as complete opening of the True™ Flow Valvuloplasty Perfusion Catheter by visual estimate and the ability of the inflated True™ Flow Valvuloplasty Perfusion balloon to stay stationary with clinically acceptable intraventricular pressure under rapid pacing, reduced pacing, or without pacing.
Freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure.
Time frame: Duration of Dilatation of Balloon during Procedure (<120 minutes)
Defined as the time the study device catheter is introduced until the time TAVI device system is introduced.
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 10 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Axel Linke, Prof.Dr.med. principal investigator
Helios Health Institute GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by C. R. Bard at 1 site 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 8 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Successful dilatation of the aortic valve using the True™ Flow Valvuloplasty Perfusion Catheter. (time frame: Duration of Dilatation of Balloon during Procedure (<120 minutes)). The study lists 2 primary outcomes in all. 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 10 Jan 2017.