Aortic Valve StenosisREPRISE EDGENCT02854319

REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

A study testing LOTUS Edge Valve System in people with Aortic Valve Stenosis, run by Boston Scientific Corporation at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for… Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: LOTUS Edge Valve System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 3 sitesin 3 countries
Study dates: 7 Sep 2016to 13 Mar 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

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 and/or invasive hemodynamics.
Note: In cases of low flow, low gradient aortic stenosis dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic criteria are met with this augmentation.
Subject has a documented aortic annulus size between ≥20 mm and ≤27 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:

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STS score ≥8%, and/or
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 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 aortic or mitral valve.
Subject has >3+ mitral regurgitation, >3+ aortic regurgitation or >3+ 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 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.
Note: An alternative P2Y12 inhibitor may be prescribed if subject is allergic to or intolerant of 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 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 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 arterial access that is not acceptable for the LOTUS Edge delivery system and its compatible Lotus or iSleeve Introducers as defined in the Directions For Use, or severe iliofemoral tortuosity or calcification that would prevent safe placement of either 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 does not have a permanent pacemaker but has a class I or II indication for pacemaker implantation (based on the latest available ESC guidelines).

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Denmark1 site

Rigshospitalet
Copenhagen

Other trials in Denmark

France1 site

Clinique Pasteur
Toulouse

Other trials in France

Sweden1 site

Skåne University Hospital
Lund

Other trials in Sweden

About this study

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

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 or Lotus Introducer Set are consistent with the results of the commercially approved 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 Valve Stenosis
Being tested: 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 Edge Valve SystemDevice
Transcatheter Aortic Valve Implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set

Study groups in NCT02854319
Study group	Role	What they receive
LOTUS Edge Valve System	Experimental	Transcatheter aortic valve implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set Receives: Device: LOTUS Edge Valve System

What is being measured

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

Mean aortic valve pressure gradient
Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory.
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first)

Secondary outcomes (5)

Technical success
Defined as successful vascular access, delivery, and deployment of a Lotus Valve; successful retrieval with the 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)
Effective orifice area
Effective orifice area as measured by echocardiography and assessed by an independent core laboratory
Measured: At discharge from hospital or at 7 days post-procedure (whichever comes first)
Successful repositioning of the study valve if repositioning is attempted
Measured: Immediately post-procedure (patient discharged from operative room)
Successful retrieval of the study valve if retrieval is attempted
Measured: Immediately post-procedure (patient discharged from operative room)
Grade of paravalvular aortic regurgitation
Grade of paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory
Measured: At discharge from hospital or at 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.

7 Sep 201613 Mar 2018

First posted3 Aug 2016 (estimated)
Study start7 Sep 2016
Primary completion25 Oct 2016
Study completion13 Mar 2018

Why it stopped: Investigational Medical Device is not available and the 15 patients enrolled completed their 1-yr follow-up per protocol

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve 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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02854319
Sponsor's protocol ID: S2367
Acronym: REPRISE EDGE
Status last verified: May 2018
First submitted: 28 Jul 2016
Last updated: 31 May 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety
ClinicalTrials.gov ID: NCT02854319
Acronym / sponsor ID: REPRISE EDGE / S2367
Conditions: Aortic Valve Stenosis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Investigational Medical Device is not available and the 15 patients enrolled completed their 1-yr follow-up per protocol
Enrolment: 15 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 7 Sep 2016 (actual)
Primary completion: 25 Oct 2016 (actual)
Study completion: 13 Mar 2018 (actual)
First posted: 3 Aug 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LOTUS Edge Valve System	Experimental	Device: LOTUS Edge Valve SystemTranscatheter aortic valve implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (11 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 and/or invasive hemodynamics.
Note: In cases of low flow, low gradient aortic stenosis dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic criteria are met with this augmentation.
Subject has a documented aortic annulus size between ≥20 mm and ≤27 mm based on pre-procedure diagnostic imaging.
Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.

Key exclusion criteria (25 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 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 aortic or mitral valve.

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 Edge Valve SystemTranscatheter Aortic Valve Implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set	Device	LOTUS Edge Valve System

Primary outcome

Mean aortic valve pressure gradient
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first)
Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory.

5 secondary outcomes

Technical success
Time frame: Immediately post-procedure (patient discharged from operative room)
Effective orifice area
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first)
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)
Grade of paravalvular aortic regurgitation
Time frame: At discharge from hospital or at 7 days post-procedure (whichever comes first)

Results and safety

The study was stopped early (reason given: Investigational Medical Device is not available and the 15 patients enrolled completed their 1-yr follow-up per protocol). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

Matthias Götberg, MD, PhD principal investigator

Skane University Hospital

Sabine Bleiziffer, MD principal investigator

German Heart Centre München

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LOTUS Edge Valve System in people with Aortic Valve Stenosis, run by Boston Scientific Corporation at 3 sites in 3 countries.

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 11 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: stopped early, as of the sponsor's last update on 31 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 3 sites in Denmark, France, Sweden. 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?

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 (time frame: At discharge from hospital or at 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 NCT02854319.

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 31 May 2018.