Aortic StenosisNGDSNCT02329496
REPRISE Next Generation Delivery System
A study testing Lotus Valve and LOTUS Edge Valve System in people with Aortic Stenosis, run by Boston Scientific Corporation at 2 sites in Australia.
Trial summary
To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Lotus Valve and LOTUS Edge Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesAustralia
- Study dates
- 3 Dec 2014to 19 Oct 2017
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject is ≥70 years of age
- Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and either a mean pressure gradient ≥40 mm Hg or a jet velocity ≥4 m/s, as measured by echocardiography.
- Subject has a documented aortic annulus size between ≥20 and ≤27.5 mm based on pre-procedure diagnostic imaging
- Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.
- Subject is considered high risk for surgical valve replacement based on at least one of the following:
- Society of Thoracic Surgeons (STS) score ≥8%, and/or
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- Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement.
- Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement
- Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
- Subject, family member and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
Who cannot join
- Subject has a congenital unicuspid or bicuspid aortic valve.
- Subject with an acute myocardial infarction within 30 days of the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin level elevation).
- Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
- Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µml/L.
- Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
- Subject has ≥3+ mitral regurgitation, ≥3+ aortic regurgitation or ≥3+ tricuspid regurgitation (i.e., subject cannot have more than moderate mitral, aortic or tricuspid regurgitation).
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- Subject has a need for emergency surgery for any reason.
- Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
- Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
- Subject has Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
- Subject is receiving chronic (≥72 hours) anticoagulation therapy (warfarin), and cannot tolerate concomitant therapy with aspirin or clopidogrel (subjects who require chronic anticoagulation must additionally be able to be treated with either aspirin or clopidogrel).*
- Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
- Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, titanium, or polyurethanes.
- Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
- Subject has hypertrophic obstructive cardiomyopathy.
- Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty and pacemaker implantation which are allowed).
- Subject has untreated coronary artery disease, which in the opinion of the treating physician, is clinically significant and requires revascularization.
- Subject has documented left ventricular ejection fraction <30%.
- Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
- Subject has severe peripheral vascular disease (including aneurysm defined as maximal luminal diameter >5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [>5 mm] protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.
- Femoral artery lumen of <6.0 mm for subjects requiring 23 mm valve size or <6.5 mm for subjects requiring 27 mm valve size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
- Current problems with substance abuse (e.g., alcohol, etc.).
- Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
- Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Prince Charles Hospital
Chermside, Queensland, 4032
Monash Heart
Clayton, Victoria, 3168
About this study
Official title: REPRISE NGDS: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With the Next Generation Delivery System
To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Read the detailed description
This clinical study is a prospective single-arm study designed to demonstrate that the acute performance and safety of the LOTUS Edge Valve System when used with the iSleeve Introducer Set or current Lotus Introducer Set are consistent with the results of the Lotus Valve System used in the REPRISE II study, when delivered and deployed in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).
- Conditions
- Aortic Stenosis
- Being tested
- Lotus Valve and LOTUS Edge Valve System
- 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.
Lotus Valve and LOTUS Edge Valve SystemDevice
Transcatheter aortic valve replacement (TAVR) with the Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System, with either the Lotus Introducer or iSleeve Introducer Sets
| Study group | Role | What they receive |
|---|---|---|
| Lotus Valve and LOTUS Edge Valve System | Experimental | Transcatheter aortic valve replacement (TAVR) with Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System Receives: Device: Lotus Valve and LOTUS Edge Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Defined as successful vascular access, delivery, and deployment of the Lotus Valve; successful retrieval with the Lotus Next Generation delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location (reported as percent of subjects implanted with a Lotus Valve). Reported as percent of subjects.
Measured: Immediately post-procedure (patient discharged from operative room)
Secondary outcomes (29)
Successful repositioning of the study valve if repositioning is attempted
Reported as percent of subjects
Measured: Immediately post-procedure (patient discharged from operative room)
Successful retrieval of the study valve if retrieval is attempted
Reported as percent of subjects
Measured: Immediately post-procedure (patient discharged from operative room)
Severe or moderate paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory
Reported as percent of subjects
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Mild, trace/trivial, or no paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory
Reported as percent of subjects
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory
Reported as mean ± standard deviation; mmHg
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Effective orifice area as measured by echocardiography and assessed by an independent core laboratory
Reported as mean ± standard deviation; cm2
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Peak aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory
Reported as mean ± standard deviation; mmHg
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Peak aortic velocity as measured by echocardiography and assessed by an independent core laboratory
Reported as mean ± standard deviation; m/sec
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Mortality: all-cause, cardiovascular, and non-cardiovascular
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Stroke: disabling and non-disabling
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Bleeding: life-threatening (or disabling) and major
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Acute kidney injury based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2
Reported as percent of subjects
Measured: ≤7 days post index procedure
Major vascular complications major
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
New permanent pacemaker implantation resulting from new or worsened conduction disturbances
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
New onset of atrial fibrillation or atrial flutter
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Coronary obstruction
Reported as percent of subjects
Measured: ≤72 hours post index procedure
Ventricular septal perforation
Reported as percent of subjects
Measured: ≤72 hours post index procedure
Mitral apparatus damage
Reported as percent of subjects
Measured: ≤72 hours post index procedure
Cardiac tamponade
Reported as percent of subjects
Measured: ≤72 hours post index procedure
Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Transcatheter aortic valve (TAV)-in-TAV deployment
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Prosthetic aortic valve thrombosis
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Prosthetic aortic valve endocarditis
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Neurological status per modified Rankin Scale score
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Neurological status per National Institutes of Health Stroke Scale
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Functional Improvement from baseline per NYHA functional classification
Reported as percent of subjects
Measured: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study start3 Dec 2014
- Primary completion6 Oct 2016
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Gooley, MD, Principal investigator, Monash
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329496
- Sponsor's protocol ID
- S2332
- Acronym
- NGDS
- Status last verified
- May 2018
- First submitted
- 19 Nov 2014
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPRISE NGDS: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With the Next Generation Delivery System
- ClinicalTrials.gov ID
- NCT02329496
- Acronym / sponsor ID
- NGDS / S2332
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- 6 Oct 2016 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 31 Dec 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.
To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Detailed description
This clinical study is a prospective single-arm study designed to demonstrate that the acute performance and safety of the LOTUS Edge Valve System when used with the iSleeve Introducer Set or current Lotus Introducer Set are consistent with the results of the Lotus Valve System used in the REPRISE II study, when delivered and deployed in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lotus Valve and LOTUS Edge Valve System | Experimental | Device: Lotus Valve and LOTUS Edge Valve SystemTranscatheter aortic valve replacement (TAVR) with Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Subject is ≥70 years of age
- Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and either a mean pressure gradient ≥40 mm Hg or a jet velocity ≥4 m/s, as measured by echocardiography.
- Subject has a documented aortic annulus size between ≥20 and ≤27.5 mm based on pre-procedure diagnostic imaging
- Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.
- Subject is considered high risk for surgical valve replacement based on at least one of the following:
Key exclusion criteria (24 listed)
- Subject has a congenital unicuspid or bicuspid aortic valve.
- Subject with an acute myocardial infarction within 30 days of the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin level elevation).
- Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
- Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µml/L.
- Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
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 |
|---|---|---|
| Lotus Valve and LOTUS Edge Valve SystemTranscatheter aortic valve replacement (TAVR) with the Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System, with either the Lotus Introducer or iSleeve Introducer Sets | Device | Lotus Valve and LOTUS Edge Valve System |
Primary outcome
Technical Success
Time frame: Immediately post-procedure (patient discharged from operative room)
Defined as successful vascular access, delivery, and deployment of the Lotus Valve; successful retrieval with the Lotus Next Generation delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location (reported as percent of subjects implanted with a Lotus Valve). Reported as percent of subjects.
29 secondary outcomes
Successful repositioning of the study valve if repositioning is attempted
Time frame: Immediately post-procedure (patient discharged from operative room)
Successful retrieval of the study valve if retrieval is attempted
Time frame: Immediately post-procedure (patient discharged from operative room)
Severe or moderate paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Mild, trace/trivial, or no paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Effective orifice area as measured by echocardiography and assessed by an independent core laboratory
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Peak aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Peak aortic velocity as measured by echocardiography and assessed by an independent core laboratory
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Mortality: all-cause, cardiovascular, and non-cardiovascular
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Stroke: disabling and non-disabling
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Bleeding: life-threatening (or disabling) and major
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Acute kidney injury based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2
Time frame: ≤7 days post index procedure
Major vascular complications major
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
New permanent pacemaker implantation resulting from new or worsened conduction disturbances
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
New onset of atrial fibrillation or atrial flutter
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Coronary obstruction
Time frame: ≤72 hours post index procedure
Ventricular septal perforation
Time frame: ≤72 hours post index procedure
Mitral apparatus damage
Time frame: ≤72 hours post index procedure
Cardiac tamponade
Time frame: ≤72 hours post index procedure
Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Transcatheter aortic valve (TAV)-in-TAV deployment
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Prosthetic aortic valve thrombosis
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Prosthetic aortic valve endocarditis
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Neurological status per modified Rankin Scale score
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Neurological status per National Institutes of Health Stroke Scale
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure
Functional Improvement from baseline per NYHA functional classification
Time frame: At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months 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 24 May 2018.
- Individual participant dataSharing planned: No
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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.
Robert Gooley, MD principal investigator
Monash
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotus Valve and LOTUS Edge Valve System in people with Aortic Stenosis, run by Boston Scientific Corporation at 2 sites in Australia.
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 10 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 24 May 2018. 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 Australia. 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?
Technical Success (time frame: Immediately post-procedure (patient discharged from operative room)). 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 24 May 2018.