Aortic Valve StenosisPostCorENCT02472106
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
An observational study of Aortic Valve Stenosis, run by InterValve, Inc..
Trial summary
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Post-dilatation
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 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 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 Medtronic CoreValve or other self-expanding TAVI device are eligible for enrollment.
Who may be able to join
- Subjects with severe symptomatic aortic stenosis (AS) indicated and scheduled for a transcatheter aortic valve implant (TAVI) with the Medtronic CoreValve or another self-expanding TAVI device.
- The TAVI device size is determined preoperatively with CTA according to standard guidelines. Patients may undergo transfemoral, subclavian, or transaortic approach.
- Balloon postdilatation (BPD) is carried out after CoreValve or other self-expanding TAVI device implantation if, based on operator's judgment, BPD is indicated because of presence of paravalvular leak (PVL).
- Hemodynamically stable for 3 - 10 minutes after the TAVI procedure.
- 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.
Who cannot join
- Cardiogenic shock, as defined by a consistent systolic blood pressure <80 mmHg off vasopressors or <90 mmHg on vasopressors.
- PVL occurring secondary to excessively high or low valve positioning.
- Trauma or significant structural damage to underlying native tissue calls for emergent intervention or threatens long-term outcome prior to the BPD.
- Patients receiving two valves (i.e. aortic THV valve in valve).
- Patients with AS secondary to congenital valve disease including bicuspid aortic valve.
- PVL occurring due to TAVI device under sizing. Example of determining the undersizing is to calculate the Cover Index which represents the percent of over sizing of the nominal transcatheter heart valve (THV) area compared to the measured native valve annulus area. Under sizing is defined as TAVI screening CTA with a pre procedure cover index by area of <5%.
- Vulnerable subjects and any subjects incapable of giving consent, including patients with incurable diseases, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and subjects with cognitive impairment, such as persons with a mental illness or dementia.
About this study
Official title: Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following Medtronic CoreValve or Other Self-Expanding TAVI Procedure (PostCorE)
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and is being investigated for an expanded intended use.
Read the detailed description
The study is a prospective, multi-center, single arm open-label clinical study involving up to 5 centers and a minimum of 20 subjects. Up to 50 subjects may be enrolled in this study. The first 3 post-dilatation procedures for each investigator will be considered roll-ins and not included in the main study analyses. Subjects will exit the study at hospital discharge or 7 days post treatment, whichever comes first. The expected duration of the clinical investigation is approximately 6 months.
Subjects implanted with the CoreValve or other commercially available self-expanding TAVI and with the use of the V8 as a postdilatation balloon may be enrolled in this study. The subject will exit the study after the predischarge ECHO where the Paravalvular Leak (PVL) measurements are taken or resolution of a V8 related AE (if applicable).
- Conditions
- Aortic Valve Stenosis
- Being tested
- Post-dilatation
- Keywords
- Aortic Valve, TAVI, Stenosis
- Medical subject headings
- Aortic Valve Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-dilatationDevice
Post-dilatation in self-expanding TAVI device procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: V8 Device Performance
Rate of successful V8 balloon fixation within the TAVI prosthesis: during rapid ventricular pacing, proximal and distal balloon segments are securely fixed on either side of the native 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 II)
Measured: Intra-procedure until discharge or 7 days post-procedure, whichever comes first. (Typical discharge is expected to be within 7 days.)
Secondary outcomes (5)
Efficacy Endpoint: Degree of Paravalvular Leak (PVL)
PVL determined by collating as many data points as possible using TTE, TEE, aortic root angiography, and/or hemodynamic measurements
Measured: Intra-Procedure
Efficacy Endpoint: Procedural Parameter - V8 Dimension
Size of V8(s) used during procedure
Measured: Intra-Procedure
Efficacy Endpoint: Procedural Parameter - CoreValve Dimension
Size of CoreValve(s) used during procedure
Measured: Intra-Procedure
Efficacy Endpoint: Procedural Parameter - Aortic Valve Measurement
Aortic Valve measurements performed during procedure
Measured: Intra-Procedure
Safety Endpoint: 24hr Complication
AE(s) defined in protocol attributable to V8 balloon post-dilatation (BPD) procedure
Measured: 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 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.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterValve, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472106
- Sponsor's protocol ID
- 1302-001
- Acronym
- PostCorE
- Status last verified
- Aug 2016
- First submitted
- 28 May 2015
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following Medtronic CoreValve or Other Self-Expanding TAVI Procedure (PostCorE)
- ClinicalTrials.gov ID
- NCT02472106
- Acronym / sponsor ID
- PostCorE / 1302-001
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve, TAVI, Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- InterValve, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Jun 2015 (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 study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and is being investigated for an expanded intended use.
Detailed description
The study is a prospective, multi-center, single arm open-label clinical study involving up to 5 centers and a minimum of 20 subjects. Up to 50 subjects may be enrolled in this study. The first 3 post-dilatation procedures for each investigator will be considered roll-ins and not included in the main study analyses. Subjects will exit the study at hospital discharge or 7 days post treatment, whichever comes first. The expected duration of the clinical investigation is approximately 6 months.
Subjects implanted with the CoreValve or other commercially available self-expanding TAVI and with the use of the V8 as a postdilatation balloon may be enrolled in this study. The subject will exit the study after the predischarge ECHO where the Paravalvular Leak (PVL) measurements are taken or resolution of a V8 related AE (if applicable).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 Medtronic CoreValve or other self-expanding TAVI device are eligible for enrollment.
Key inclusion criteria (6 listed)
- Subjects with severe symptomatic aortic stenosis (AS) indicated and scheduled for a transcatheter aortic valve implant (TAVI) with the Medtronic CoreValve or another self-expanding TAVI device.
- The TAVI device size is determined preoperatively with CTA according to standard guidelines. Patients may undergo transfemoral, subclavian, or transaortic approach.
- Balloon postdilatation (BPD) is carried out after CoreValve or other self-expanding TAVI device implantation if, based on operator's judgment, BPD is indicated because of presence of paravalvular leak (PVL).
- Hemodynamically stable for 3 - 10 minutes after the TAVI procedure.
- Probable survival to hospital discharge.
Key exclusion criteria (7 listed)
- Cardiogenic shock, as defined by a consistent systolic blood pressure <80 mmHg off vasopressors or <90 mmHg on vasopressors.
- PVL occurring secondary to excessively high or low valve positioning.
- Trauma or significant structural damage to underlying native tissue calls for emergent intervention or threatens long-term outcome prior to the BPD.
- Patients receiving two valves (i.e. aortic THV valve in valve).
- Patients with AS secondary to congenital valve disease including bicuspid aortic valve.
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 |
|---|---|---|
| Post-dilatationPost-dilatation in self-expanding TAVI device procedures | Device | – |
Primary outcome
Efficacy Endpoint: V8 Device Performance
Time frame: Intra-Procedure
Rate of successful V8 balloon fixation within the TAVI prosthesis: during rapid ventricular pacing, proximal and distal balloon segments are securely fixed on either side of the native aortic valve annulus following inflation
Safety Endpoint: Serious Adverse Events (SAE)
Time frame: Intra-procedure until discharge or 7 days post-procedure, whichever comes first. (Typical discharge is expected to be within 7 days.)
The composite of SAEs as defined by the Valve Academic Research Consortium (VARC II)
5 secondary outcomes
Efficacy Endpoint: Degree of Paravalvular Leak (PVL)
Time frame: Intra-Procedure
Efficacy Endpoint: Procedural Parameter - V8 Dimension
Time frame: Intra-Procedure
Efficacy Endpoint: Procedural Parameter - CoreValve Dimension
Time frame: Intra-Procedure
Efficacy Endpoint: Procedural Parameter - Aortic Valve Measurement
Time frame: Intra-Procedure
Safety Endpoint: 24hr Complication
Time frame: 24 hours post-procedure
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 31 Aug 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by InterValve, Inc..
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 6 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: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 31 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.