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Aortic Valve StenosisREPRISE INCT01383720

REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

A study testing Lotus Valve System in people with Aortic Valve Stenosis and Aortic Valve Calcification, run by Boston Scientific Corporation at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Lotus Valve System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesAustralia
Study dates
Apr 2012to 9 May 2017
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient must be at least 70 years of age or older, and meets all of the criteria below.
  • Patient has documented calcified native aortic valve stenosis, defined with an initial aortic valve area (AVA) of <1.0 cm2 (or AVA index of <0.6 cm2/m2), and a mean pressure gradient >40 mmHg or a jet velocity >4 m/s, as measured by echocardiography.
  • The patient is considered at high risk for surgical aortic valve replacement with an STS (Society of Thoracic Surgeons) score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities.
  • Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II.
  • Patient has a documented aortic annulus size between 19 and 22 mm (able to accommodate the 23 mm Lotus™ Valve). Pre-procedure measurement by transthoracic echocardiography (TTE) is required. Other imaging modalities (e.g., transesophageal echocardiography (TEE), CT scan) can be used in an adjunctive manner.
  • Patient (or legal representative) understands the trial requirements and the treatment procedures, and provides written informed consent.
  • Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

Who cannot join

  • Patient has a congenital unicuspid or bicuspid aortic valve.
  • Patient with an acute myocardial infarction (MI) within 30 days of the index procedure (defined as Q wave MI, or non-Q wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation (WHO definition)).
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
  • Patient is on dialysis or has serum creatinine level >3.0 mg/dL.
  • Patient has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
  • Patient has >2+ mitral regurgitation or >2+ aortic regurgitation (ie., patient cannot have more than moderate mitral or aortic regurgitation).
Show all 27Show fewer
  • Moderate to severe pulmonary hypertension (PA systolic pressure >60 mm Hg) as assessed by transthoracic echocardiography.
  • Patient has a need for emergency surgery for any reason.
  • Patient has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
  • Patient has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
  • Patient has Hgb <9 g/dL, platelet count <100,000 cells/mm3 or >700,000 cells/mm3, and white blood cell (WBC) count <3,000 cells/mm3.
  • Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) and who cannot tolerate concomitant therapy with aspirin and clopidogrel (patients who require chronic anticoagulation must be treated with either aspirin or clopidogrel).
  • Patient has active peptic ulcer disease, gastrointestinal (GI) bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
  • Patient is contraindicated for transesophageal echocardiography (TEE).
  • Patient 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.
  • Patient 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.
  • Patient has other cardiac devices or hardware with which the study device will interfere with device placement (per physician judgment).
  • Patient has hypertrophic obstructive cardiomyopathy.
  • Patient has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Patient has documented left ventricular ejection fraction (LVEF) <30%.
  • Patient is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • Patient has severe peripheral vascular disease (including aneurysm defined as maximal luminal diameter >5cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick (>5mm), protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.
  • Patient has a femoral artery lumen of <6.0 mm or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
  • Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc).
  • Patient is participating in another investigational drug or device study that has not reached its primary endpoint.
  • Patient has preexisting untreated conduction system disorders: Type II second-degree atrioventricular (AV) block, bifascicular or trifascicular block.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St. Vincent's Hospital

    Melbourne, Victoria, 3040

  • Southern Health Monash Medical Centre

    Melbourne, Victoria, 3168

Other trials in Australia

About this study

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.

Read the detailed description

The incidence of aortic stenosis is increasing due to the aging of the world-wide population and the lack of drug therapies to prevent, halt, or effectively slow the stenotic process. Transcatheter aortic valve replacement has become a viable alternative for treatment of severe symptomatic aortic stenosis in selected patients who are unsuitable candidates for surgical valve replacement. The Lotus Valve System is designed to enable precise placement and minimize or eliminate the paravalvular regurgitation and associated adverse events seen with earlier generation devices. The REPRISE I study assesses acute safety and performance.

Being tested
Lotus Valve System
Keywords
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Medical subject headings
Aortic Valve Stenosis, Aortic Valve, Calcification of, Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lotus Valve SystemDevice

    The Lotus Valve System includes the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter for guidance and placement.

Study groups in NCT01383720
Study groupRoleWhat they receive
Lotus Valve SystemExperimentalPatients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Receives: Device: Lotus Valve System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Procedural Success

    Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.

    Measured: Discharge or 7 days post-procedure, whichever comes first

Secondary outcomes (4)

  1. Device Performance Endpoint-Repositioning

    Successful repositioning of the Lotus Valve System if repositioning is attempted

    Measured: procedure

  2. Device Performance Endpoint-Valve Retrieval, if Attempted

    Successful retrieval of the Lotus Valve System if retrieval is attempted

    Measured: procedure

  3. Central Aortic Regurgitation

    As determined by echocardiography

    Measured: Discharge or 7 days post-procedure, whichever comes first

  4. Paravalvular Aortic Regurgitation

    As determined by echocardiography

    Measured: Discharge or 7 days post-procedure, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2012
  4. Study completion9 May 2017

Resources

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01383720
Sponsor's protocol ID
TP3659
Acronym
REPRISE I
Status last verified
May 2017
First submitted
27 Jun 2011
Last updated
20 Jun 2017
Data monitoring committee
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available.

Questions about this trial

What is this clinical trial studying?

A study testing Lotus Valve System in people with Aortic Valve Stenosis and Aortic Valve Calcification, run by Boston Scientific Corporation at 3 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 7 inclusion and 27 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 9 May 2016). 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?

Clinical Procedural Success (time frame: Discharge or 7 days post-procedure, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01383720.

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 20 Jun 2017.

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