Aortic Valve StenosisPhase 1/2NCT01721642
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
A Phase 1/2 study testing Apica Cardiovascular ASC Access, Stability and Closure Device in people with Aortic Valve Stenosis, run by Apica Cardiovascular Limited.
Trial summary
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. 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?
- Apica Cardiovascular ASC Access, Stability and Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 1/2
- 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
Who may be able to join
- Subject age ≥ 18 years of age.
- Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. Subjects selected will meet all of the TAVI inclusion criteria as follows:
- Subject has Senile degenerative aortic stenosis with echocardiography derived criteria: mean gradient > 40 mm Hg or jet velocity > 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2.
- Subject is symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class > II.
- Additive EuroScore > 9
- Aortic annulus diameter > 21mm to < 27mm by TEE
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- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- The subject, after formal consults by a cardiologist and two cardiovascular surgeons agreed that medical factors precluding operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeded the probability of meaningful improvement. Specifically the probability of death or serious, irreversible morbidity exceeded 50%.
Who cannot join
- Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. The following TAVI exclusion criteria shall apply:
- Evidence of an acute myocardial infarction < 1 month before the intended treatment
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
- Pre-existing prosthetic heart valve in an position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
- Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
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- Untreated clinically significant coronary artery disease requiring revascularization
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
- Need for emergency surgery for any reason
- Hypertrophic cardiomyopathy with or without obstruction
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
- A known hypersensitivity of contraindication to asprin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated
- Recent (within 6 months) cerebrovascular accident or transient ischemic attack
- Renal insufficiency and/or end stage renal disease requiring chronic dialysis.
- Life expectancy < 12 months due to non-cardiac co-morbid conditions.
- The following ASC device exclusion criteria shall apply:
- Subjects with <10mm Left ventricular wall thickness at apical access site
- LVEF < 30%
- Subject with previous DOR procedure
- Subject access site has less than 2 cm squared "fat" free area under visual observation
- Subject has known Allergy or hypersensitivity to Titanium
- Subject requires MR Imaging post procedure
- Subject is Pregnant
About this study
Official title: A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device During and After Transcatheter Aortic Valve Implantation (TAVI) Procedures
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made post-procedure, at 30 days and 90 days as well as longer term follow-up.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Apica Cardiovascular ASC Access, Stability and Closure Device
- Keywords
- access, closure, trans-apical, trans-catheter aortic valve implantation, TAVI, trans-catheter aortic valve repair, TAVR
- 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.
Apica Cardiovascular ASC Access, Stability and Closure DeviceDevice
Also called Apica Cardiovascular, ASC
Access, stabilisation and closure of trans-apical approach for TAVI
| Study group | Role | What they receive |
|---|---|---|
| Apica Cardiovascular ASC Device | Experimental | Access, stabilisation and closure with the Apica Cardiovascular ASC Device Receives: Device: Apica Cardiovascular ASC Access, Stability and Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access safety
Observation of no myocardial tearing on entry of the device
Measured: Within 2 hours from initial skin incision
Closure safety
Observation of no acute post-procedural bleeding or pericardial effusion.
Measured: Within 2 hours from initial skin incision
Secondary outcomes (1)
Investigational device performance: LV function
% LVEF no worse than baseline as assessed by echocardiography
Measured: 24 hours, 30 days and 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionMar 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apica Cardiovascular Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Walther, Prof, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721642
- Sponsor's protocol ID
- CIP-DP1
- Status last verified
- Jun 2014
- First submitted
- 25 Sep 2012
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device During and After Transcatheter Aortic Valve Implantation (TAVI) Procedures
- ClinicalTrials.gov ID
- NCT01721642
- Acronym / sponsor ID
- CIP-DP1
- Conditions
- Aortic Valve Stenosis
- Keywords
- access, closure, trans-apical, trans-catheter aortic valve implantation, TAVI, trans-catheter aortic valve repair, TAVR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Apica Cardiovascular LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Nov 2012 (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.
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made post-procedure, at 30 days and 90 days as well as longer term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apica Cardiovascular ASC Device | Experimental | Device: Apica Cardiovascular ASC Access, Stability and Closure DeviceAccess, stabilisation and closure with the Apica Cardiovascular ASC Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject age ≥ 18 years of age.
- Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. Subjects selected will meet all of the TAVI inclusion criteria as follows:
Key exclusion criteria (24 listed)
- Subjects will be selected in accordance with the investigating centers standard operating procedures for TAVI subject selection and treatment. The following TAVI exclusion criteria shall apply:
- Evidence of an acute myocardial infarction < 1 month before the intended treatment
- Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
- Pre-existing prosthetic heart valve in an position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
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 |
|---|---|---|
| Apica Cardiovascular ASC Access, Stability and Closure DeviceAlso: Apica Cardiovascular, ASCAccess, stabilisation and closure of trans-apical approach for TAVI | Device | Apica Cardiovascular ASC Device |
Primary outcome
Access safety
Time frame: Within 2 hours from initial skin incision
Observation of no myocardial tearing on entry of the device
Closure safety
Time frame: Within 2 hours from initial skin incision
Observation of no acute post-procedural bleeding or pericardial effusion.
1 secondary outcome
Investigational device performance: LV function
Time frame: 24 hours, 30 days and 90 days 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 27 Jun 2014.
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Thomas Walther, Prof principal investigator
Kerckhoff Klinik
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apica Cardiovascular ASC Access, Stability and Closure Device in people with Aortic Valve Stenosis, run by Apica Cardiovascular Limited.
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 9 inclusion and 24 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 27 Jun 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Access safety (time frame: Within 2 hours from initial skin incision). 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 27 Jun 2014.