Aortic StenosisNCT02903420
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Aortic Stenosis, run by Edwards Lifesciences at 2 sites in Japan.
Trial summary
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- 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
- 38 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2016to Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
- Patient has senile degenerative aortic valve stenosis
- Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
- Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.
Who cannot join
- Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
- Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
- Patient has severe aortic valve regurgitation.
- Patient has severe mitral valve regurgitation.
- Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
- Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Osaka University Hospital
Suita, Osaka, 565-0871
About this study
Official title: A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Read the detailed description
1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- 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.
Transcatheter Aortic Valve Implantation (TAVI)Device
Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
| Study group | Role | What they receive |
|---|---|---|
| SAPIEN 3 | Experimental | Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System Receives: Device: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of Deaths
Measured: 1 year
Secondary outcomes (2)
Device Success
Number of patients with device success, defined as absence of procedural mortality, correct positioning of a study valve into the proper anatomical location, and intended performance of the study valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, and no moderate or severe prosthetic valve regurgitation).
Measured: 30 days
Hospitalization Length of Stay
Discharge is defined as an average for 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion14 Feb 2019
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshiki Sawa, Principal investigator, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903420
- Sponsor's protocol ID
- EW-P-003
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2016
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT02903420
- Acronym / sponsor ID
- EW-P-003
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Detailed description
1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAPIEN 3 | Experimental | Device: Transcatheter Aortic Valve Implantation (TAVI)Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
- Patient has senile degenerative aortic valve stenosis
- Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
- Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.
Key exclusion criteria (6 listed)
- Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
- Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
- Patient has severe aortic valve regurgitation.
- Patient has severe mitral valve regurgitation.
- Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
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)Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach. | Device | SAPIEN 3 |
Primary outcome
Mortality
Time frame: 1 year
Number of Deaths
2 secondary outcomes
Device Success
Time frame: 30 days
Hospitalization Length of Stay
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis
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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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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.
Yoshiki Sawa principal investigator
Osaka University Hospital
2 sites 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 Aortic Stenosis, run by Edwards Lifesciences at 2 sites in Japan.
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 6 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality (time frame: 1 year). 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 25 Sep 2024.