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Aortic Valve StenosisNCT02964962

REPRISE EDGE 29 mm EU Study

A study testing 29 mm LOTUS Edge™ Valve System in people with Aortic Valve Stenosis, run by Boston Scientific Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical aortic valve… Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
29 mm LOTUS Edge™ Valve System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Apr 2018to 30 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 and/or invasive hemodynamics.
  • Subject has a documented aortic annulus size of ≥27 mm and ≤29 mm based on the site's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]).
  • Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.
  • There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see Note 5 below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate.
  • Additionally, subject has at least one of the following:
  • Society of Thoracic Surgeons (STS) score ≥8% -OR-
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  • If STS <8, subject has at least one of the following conditions:
  • Hostile chest
  • Porcelain aorta
  • Severe pulmonary hypertension (>60 mmHg)
  • Prior chest radiation therapy
  • Coronary artery bypass graft(s) at risk with re-operation
  • Severe lung disease (need for supplemental oxygen, FEV1 <50% of predicted, DLCO <60%, or other evidence of severe pulmonary dysfunction)
  • Neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement
  • Orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement
  • Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial)
  • Frailty as indicated by at least one of the following: 5-meter walk >6 seconds, Katz ADL score of 3/6 or less, body mass index <21, wheelchair bound, unable to live independently
  • Age ≥90 years
  • Other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)
  • Note 5: Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a site cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon). Extreme operative risk and high operative risk are defined as follows:
  • Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days.
  • High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days.
  • Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) agrees 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 CK-MB elevation and/or troponin level elevation).
  • Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
  • Subject has end-stage renal disease or has GFR <20 (based on Cockcroft-Gault formula).
  • Subject has a pre-existing prosthetic aortic or mitral valve.
  • Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
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  • Subject has a need for emergency surgery for any reason.
  • Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
  • Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
  • 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 after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
  • Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
  • Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
  • Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
  • Subject has hypertrophic obstructive cardiomyopathy.
  • Subject has any therapeutic invasive cardiac or vascular 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 severe left ventricular dysfunction with ejection fraction <20%.
  • Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • Subject has severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid or vertebral disease).
  • Subject has thick (>5 mm) protruding or ulcerated atheroma in the aortic arch.
  • Subject has arterial access that is not acceptable for the LOTUS Edge delivery system and its compatible Lotus Introducer as defined in the Instructions For Use.
  • Subject has 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 (based on the latest available ESC guidelines). Enrollment is permissible after permanent pacemaker implantation.
  • Subject has severe incapacitating dementia.

About this study

Official title: REPRISE EDGE 29 mm EU Study: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE 29 mm Valve - Evaluation of Safety and Performance

The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical aortic valve replacement (SAVR).

Being tested
29 mm 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.

  • 29 mm LOTUS Edge™ Valve SystemDevice

    Transcatheter aortic valve replacement

Study groups in NCT02964962
Study groupRoleWhat they receive
29 mm LOTUS Edge™ExperimentalNot described
Receives: Device: 29 mm LOTUS Edge™ Valve System

What is being measured

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

  1. Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory.

    Measured: 30 days post-procedure

Timeline

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

  1. First posted16 Nov 2016 (estimated)
  2. Study start1 Apr 2018 (estimated)
  3. Primary completion30 Oct 2018 (estimated)
  4. Study completion30 Dec 2018 (estimated)

Why it stopped: Currently not moving forward with the study

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964962
Sponsor's protocol ID
S2351
Status last verified
Jul 2019
First submitted
13 Nov 2016
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 29 mm LOTUS Edge™ Valve System in people with Aortic Valve Stenosis, run by Boston Scientific Corporation.

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 25 inclusion and 26 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: withdrawn, 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.

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 was withdrawn before enrolling participants, so there are no results.

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?

Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory. (time frame: 30 days 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 NCT02964962.

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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REPRISE EDGE 29 mm EU Study (NCT02964962) | AzTrials