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Aortic StenosisNCT03043404

Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

A study testing Transcatheter aortic valve replacement in people with Aortic Stenosis, run by Boston Scientific Corporation at 2 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

To confirm the acute performance and safety of the Lotus™ Valve Flex 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?
Transcatheter aortic valve replacement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesAustralia
Study dates
3 Dec 2013to 10 Dec 2018
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

  • 1. Subject is ≥70 years of age
  • 2. 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
  • 3. Subject has a documented aortic annulus size between ≥20 and ≤27 mm based on pre-procedure diagnostic imaging
  • 4. Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
  • 5. 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
  • 6. Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
  • 7. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
  • 8. 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 CK-MB elevation and/or troponin 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 µmol/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 requires chronic anticoagulation therapy (warfarin) and cannot tolerate concomitant therapy with either aspirin or clopidogrel.
  • Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel. An alternative P2Y12 inhibitor may be prescribed if subject is allergic to or intolerant of 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, tantalum, 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 (including balloon aortic valvuloplasty) within 30 days prior to the index procedure (except for pacemaker implantation which is 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

Other trials in Australia

About this study

Official title: REPRISE II FLEX: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With a FLEXible Delivery System - Confirmation of Performance and Safety

To confirm the acute performance and safety of the Lotus™ Valve Flex 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 confirm that the acute performance and safety of the Lotus Valve Flex System for TAVR are consistent with the results of the Lotus Valve System 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
Transcatheter aortic valve replacement
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 replacementDevice

    TAVR with Lotus Valve Flex System

Study groups in NCT03043404
Study groupRoleWhat they receive
Lotus Valve Flex SystemExperimentalTranscatheter aortic valve replacement (TAVR) with Lotus Valve FLEX System
Receives: Device: Transcatheter aortic valve replacement

What is being measured

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

  1. Technical success

    defined as successful vascular access, delivery and deployment of the Lotus Valve and successful retrieval of the delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location; reported as percent of subjects.

    Measured: immediately post-procedure

Secondary outcomes (2)

  1. Mean aortic valve pressure gradient and effective orifice area

    as measured by echocardiography and assessed by an independent core laboratory

    Measured: at discharge or 7 days post-procedure (whichever comes first)

  2. Device performance

    defined as successful repositioning of the Lotus Valve if repositioning is attempted; and successful retrieval of the Lotus Valve if retrieval is attempted; and grade of paravalvular aortic regurgitation, as measured by echocardiography and assessed by an independent core laboratory

    Measured: at 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 posted6 Feb 2017 (estimated)
  2. Study start3 Dec 2013
  3. Primary completion10 Dec 2013
  4. Study completion10 Dec 2018

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03043404
Sponsor's protocol ID
S2321
Status last verified
Jul 2019
First submitted
1 Feb 2017
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter aortic valve replacement 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 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 5 Jul 2019. 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). 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 NCT03043404.

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 5 Jul 2019.

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