Aortic Valve StenosisTAB-RNCT02099942
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
An observational study of Aortic Valve Stenosis, run by InterValve, Inc. at 7 sites in United States.
Trial summary
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2014to Dec 2015
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic - Patients at each enrolling clinic who are to be treated with the InterValve V8 device for balloon aortic valvuloplasty (BAV) are eligible for enrollment.
Who may be able to join
- Symptomatic severe aortic stenosis (AS) patients who are not suitable candidates for aortic valve replacement surgery at the time of BAV procedure.
- Subject meets the Indication For Use.
- Probable survival to hospital discharge.
- Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form. Alternatively, the legal guardian of the patient is able to give consent to participate.
Who cannot join
- Patient has undergone previous AVR
- Greater or equal to 3+ aortic insufficiency by echocardiogram obtained prior to planned BAV or intra-procedural predilation TAVR procedure
- Non-valvular AS
- Known congenital AV abnormality (e.g., bicuspid AV)
- Cardiogenic shock, as defined by a consistent systolic blood pressure <80 mmHg off vasopressors or <90 mmHg on vasopressors.
- Bacterial endocarditis ≤ 12 months prior to planned BAV procedure
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- Unable to take aspirin (acetyl salicylic acid, ASA) or thienopyridine
- Any illness or condition which, in the Investigator's judgment, will compromise patient safety, or interfere with the interpretation of the treatment results
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Good Samaritin Hospital
Los Angeles, California, 90017
University of Southern Califormia
Los Angeles, California, 90033
Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation)
Minneapolis, Minnesota, 55407
Centennial Heart
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802
Henrico's Doctors' Hospital
Richmond, Virginia, 23229
University of Washington
Seattle, Washington, 98195
About this study
Official title: Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care
Read the detailed description
The study is an open-label observational study involving a minimum of 10 centers. A minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV) treatment patients, will be enrolled. Enrollment will continue until all 3 of these conditions are met.
BAV-only patients will be followed through a 6-month post-treatment telephone follow up. Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or at 6 months post-BAV treatment, whichever comes first.
- Conditions
- Aortic Valve Stenosis
- Being tested
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Keywords
- Balloon Aortic Valvuloplasty, Valvuloplasty, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- 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.
V8 Balloon Aortic Valvuloplasty (BAV) CatheterDevice
The V8 device can be used for BAV as follows:
- as stand-alone intervention
- as a bridge to transcatheter aortic valve replacement (TAVR)
- as a bridge to surgical aortic valve replacement (SAVR)
- as an intraprocedural predilatation prior to TAVR
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: V8 Device Performance
Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation.
Measured: Intra-procedure
Safety Endpoint: Serious Adverse Events (SAE)
The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).
Measured: Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.)
Secondary outcomes (4)
Efficacy Endpoint: Intra-Procedure Hemodynamic Changes
Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
Measured: Intra-procedure
Efficacy Endpoint: Post-Procedure Hemodynamic Changes
Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
Measured: Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.)
Safety Endpoint: Aortic Valve (AV) Block at Discharge
Measured: At discharge, which is expected to be within 72 hours procedure.
Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up
Measured: 6-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- InterValve, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099942
- Sponsor's protocol ID
- 1058-001
- Acronym
- TAB-R
- Status last verified
- Feb 2016
- First submitted
- 18 Mar 2014
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
- ClinicalTrials.gov ID
- NCT02099942
- Acronym / sponsor ID
- TAB-R / 1058-001
- Conditions
- Aortic Valve Stenosis
- Keywords
- Balloon Aortic Valvuloplasty, Valvuloplasty, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- InterValve, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Mar 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.
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care
Detailed description
The study is an open-label observational study involving a minimum of 10 centers. A minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV) treatment patients, will be enrolled. Enrollment will continue until all 3 of these conditions are met.
BAV-only patients will be followed through a 6-month post-treatment telephone follow up. Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or at 6 months post-BAV treatment, whichever comes first.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic - Patients at each enrolling clinic who are to be treated with the InterValve V8 device for balloon aortic valvuloplasty (BAV) are eligible for enrollment.
Key inclusion criteria (4 listed)
- Symptomatic severe aortic stenosis (AS) patients who are not suitable candidates for aortic valve replacement surgery at the time of BAV procedure.
- Subject meets the Indication For Use.
- Probable survival to hospital discharge.
- Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form. Alternatively, the legal guardian of the patient is able to give consent to participate.
Key exclusion criteria (9 listed)
- Patient has undergone previous AVR
- Greater or equal to 3+ aortic insufficiency by echocardiogram obtained prior to planned BAV or intra-procedural predilation TAVR procedure
- Non-valvular AS
- Known congenital AV abnormality (e.g., bicuspid AV)
- Cardiogenic shock, as defined by a consistent systolic blood pressure <80 mmHg off vasopressors or <90 mmHg on vasopressors.
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 |
|---|---|---|
| V8 Balloon Aortic Valvuloplasty (BAV) CatheterThe V8 device can be used for BAV as follows: * as stand-alone intervention * as a bridge to transcatheter aortic valve replacement (TAVR) * as a bridge to surgical aortic valve replacement (SAVR) * as an intraprocedural predilatation prior to TAVR | Device | – |
Primary outcome
Efficacy Endpoint: V8 Device Performance
Time frame: Intra-procedure
Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation.
Safety Endpoint: Serious Adverse Events (SAE)
Time frame: Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.)
The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).
4 secondary outcomes
Efficacy Endpoint: Intra-Procedure Hemodynamic Changes
Time frame: Intra-procedure
Efficacy Endpoint: Post-Procedure Hemodynamic Changes
Time frame: Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.)
Safety Endpoint: Aortic Valve (AV) Block at Discharge
Time frame: At discharge, which is expected to be within 72 hours procedure.
Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up
Time frame: 6-Month Follow-up
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 1 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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 InterValve, Inc. at 7 sites in United States.
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 9 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Efficacy Endpoint: V8 Device Performance (time frame: Intra-procedure). 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 1 Mar 2016.