Symptomatic Aortic StenosisSJM TAVI FIHNCT01487330
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Symptomatic Aortic Stenosis, run by Abbott Medical Devices at 1 site in United Kingdom.
Trial summary
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Sep 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent for participation prior to procedure.
- Legal age in host country.
- Aortic annulus 19-21mm diameter
- Senile degenerative aortic stenosis with derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2)
- NYHA Functional Classification of II or greater.
- Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
Who cannot join
- History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
- Carotid artery disease requiring intervention.
- Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
- Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
- Aortic root angulation >70 degrees (horizontal aorta).
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- Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%.
- Untreated coronary artery disease (CAD) requiring revascularization.
- Severe basal septal hypertrophy.
- Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
- Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation.
- Evidence of intracardiac mass, thrombus, or vegetation.
- Hemodynamic instability
- Significant pulmonary disease.
- Nonreactive pulmonary hypertension.
- Chronic steroid use.
- Hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis.
- Morbid obesity defined as BMI ≥ 35.
- Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass.
- Ongoing infection or sepsis.
- Blood dyscrasias
- Significant aortic disease.
- Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
- Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS).
This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.
Read the detailed description
Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
- Conditions
- Symptomatic Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI, TAVR
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Device
Placement of the SJM TAVI aortic valve with a transfemoral delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving TAVI valve | Experimental | Not described Receives: Device: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Technical Feasibility and Device Deployment Characteristics
Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by:
- The ability for the valve to be deployed at the desired location
- The ability to complete the full procedure
- Quantification of the time from delivery system entry to a fully deployed and functional valve
Measured: At time of procedure
Secondary outcomes (1)
Quantification of SAEs Reported (Device Related or Procedure Related)
Evaluate the safety of the 23mm SJM Transcatheter Aortic Heart Valve and transfemoral delivery system by:
- Summarizing the SAEs observed at procedure that are device or procedure related
- Summarizing the SAEs observed during the study
Measured: Through 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ganesh Manoharan, MD, Principal investigator, Royal Victoria Hospital, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487330
- Sponsor's protocol ID
- 1103
- Acronym
- SJM TAVI FIH
- Status last verified
- Feb 2019
- First submitted
- 1 Aug 2011
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)
- ClinicalTrials.gov ID
- NCT01487330
- Acronym / sponsor ID
- SJM TAVI FIH / 1103
- Conditions
- Symptomatic Aortic Stenosis
- Keywords
- aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI, TAVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Dec 2011 (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 purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS).
This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.
Detailed description
Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving TAVI valve | Experimental | Device: Transcatheter Aortic Valve Implantation (TAVI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written Informed Consent for participation prior to procedure.
- Legal age in host country.
- Aortic annulus 19-21mm diameter
- Senile degenerative aortic stenosis with derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2)
- NYHA Functional Classification of II or greater.
Key exclusion criteria (25 listed)
- History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
- Carotid artery disease requiring intervention.
- Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
- Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
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 |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI)Placement of the SJM TAVI aortic valve with a transfemoral delivery system. | Device | Subjects receiving TAVI valve |
Primary outcome
Assessment of Technical Feasibility and Device Deployment Characteristics
Time frame: At time of procedure
Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by: 1. The ability for the valve to be deployed at the desired location 2. The ability to complete the full procedure 3. Quantification of the time from delivery system entry to a fully deployed and functional valve
1 secondary outcome
Quantification of SAEs Reported (Device Related or Procedure Related)
Time frame: Through 12 months post implantation
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 4 Feb 2019.
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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.
Ganesh Manoharan, MD principal investigator
Royal Victoria Hospital, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Symptomatic Aortic Stenosis, run by Abbott Medical Devices at 1 site in United Kingdom.
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 7 inclusion and 25 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 4 Feb 2019. 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 United Kingdom. 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?
Assessment of Technical Feasibility and Device Deployment Characteristics (time frame: At time of procedure). 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 4 Feb 2019.