Aortic Valve StenosisREPRISE IVNCT03618095

REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects

A study testing LOTUS Edge Valve System in people with Aortic Valve Stenosis, run by Boston Scientific Corporation at 50 sites in 2 countries.

Terminated

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

Official record

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Trial summary

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects Read more about this study

Who is it for?: Ages 18 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: 382 participants
Where: 50 sitesin 2 countries
Study dates: 14 Jan 2019to 31 Mar 2021
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has documented severe aortic stenosis defined as initial aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mm Hg OR maximal aortic valve velocity ≥4.0 m/s OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), 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. (IC1)
A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on computed tomography (CT) assessment and confirmed by the CT core lab with hemodynamic parameters that meet the criteria in IC1.
Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]).
Subject has symptomatic aortic valve stenosis per IC1 definition above with New York Heart Association (NYHA) Functional Class ≥ II.
Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality (≥3% and <8% at 30 days based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the risk calculator) and TAVR is appropriate. Note: Risk of operative mortality must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).
Heart team agrees that the subject is likely to benefit from valve replacement. IC7. Subject (or legal representative) has been informed of 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.
Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

Who cannot join

Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry cohort).
Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab. Subjects are not eligible for inclusion in the Bicuspid Nested Registry cohort if the maximum diameter of the ascending aorta is >45 mm or if the subject has another indication for aortic root replacement. Subjects with a Sievers Type 2 bicuspid valve are not eligible for enrollment in any study cohort.
Subject has had an acute myocardial infarction (MI) within 30 days prior to 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 creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
Subject is on renal replacement therapy or has Glomerular Filtration Rate (GFR) <20 (based on hospital preferred method). See AEC1 below if subject is in the CT Imaging Substudy.
Subject has a pre-existing prosthetic aortic or mitral valve.

Show all 26Show fewer

Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
Subject has moderate to severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or Dc).
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 platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
Subject will refuse transfusions or 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.
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 24 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
Subject has hypertrophic cardiomyopathy.
Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker or implantable cardioverter defibrillator implantation, which are allowed).
Subject has multivessel coronary artery disease with a Syntax score >22, and/or an unprotected left main coronary artery.
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 arterial access that is not acceptable for the study device delivery system as defined in the device Instructions For Use.
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 thick, protruding, ulcerated atheroma in the aortic arch).
Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.
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. Enrollment is permissible after permanent pacemaker implantation.
Subject has severe incapacitating dementia.

Trial locations and contacts

50 sites in 2 countries.

Country

City, postcode or hospital

50 sites in 2 countries

United States49 sites

Inova Fairfax Hospital
Annandale, Virginia, 22042
Piedmont Heart Institute
Atlanta, Georgia, 30309
JFK Medical Center
Atlantis, Florida, 33462
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Mills-Peninsula Medical Center - Sutter Health
Burlingame, California, 94010
Novant Health Heart & Vascular Institute - Charlotte
Charlotte, North Carolina, 28204
The Lindner Center for Research and Education
Cincinnati, Ohio, 45219
Saint Joseph Hospital
Denver, Colorado, 80218
Englewood Hospital
Englewood, New Jersey, 07631
NorthShore University HealthSystem
Evanston, Illinois, 60201
Charlton Memorial Hospital - Southcoast Health
Fall River, Massachusetts, 02720
North Florida Regional Medical Center
Gainesville, Florida, 32605
Spectrum Health - Grand Rapids
Grand Rapids, Michigan, 49503
Greenville Memorial Hospital - Prisma Health
Greenville, South Carolina, 29605
Memorial Hermann - Texas Medical Center
Houston, Texas, 77030
University of Texas - Memorial Hermann Southwest
Houston, Texas, 77030
Huntsville Hospital
Huntsville, Alabama, 35801
Indiana University Health - Methodist Hospital
Indianapolis, Indiana, 46202
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
USC Medical Center
Los Angeles, California, 90033
North Shore University Hospital
Manhasset, New York, 11030
Wellstar Research Institute
Marietta, Georgia, 30060
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Froedtert Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU Winthrop Hospital
Mineola, New York, 11501
WVU Heart & Vascular Institute
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07960
Centennial Medical Center
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Yale New Haven Hospital
New Haven, Connecticut, 06510
Ochsner Medical Center
New Orleans, Louisiana, 70121
NYU Langone Medical Center
New York, New York, 10010
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
AdventHealth Orlando
Orlando, Florida, 32803
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Baylor Scott & White The Heart Hospital
Plano, Texas, 75093
Providence St. Vincent Medical Center
Portland, Oregon, 97225
UNC Rex Hospital
Raleigh, North Carolina, 27607
Beaumont Hospital
Royal Oak, Michigan, 48073
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Swedish Medical Center
Seattle, Washington, 98122
University of Washington
Seattle, Washington, 98195
Tucson Medical Center
Tucson, Arizona, 85712
Medstar Heart and Vascular Institute
Washington D.C., District of Columbia, 20010
Via Christi Hospital
Wichita, Kansas, 67214

Other trials in United States

Australia1 site

Monash Cardiovascular Research Centre
Clayton, Victoria, 3168

Other trials in Australia

About this study

Official title: REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Read the detailed description

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.

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
TAVR with the LOTUS Edge Valve System

Study groups in NCT03618095
Study group	Role	What they receive
Main Cohort	Experimental	Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System Receives: Device: LOTUS Edge Valve System
Roll-In Cohort	Experimental	Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System Receives: Device: LOTUS Edge Valve System
Bicuspid Cohort	Experimental	Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System Receives: Device: LOTUS Edge Valve System

What is being measured

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

Composite of All-cause Mortality and All Stroke.
Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC)
Measured: 1 year post index procedure and device implantation

Timeline

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

14 Jan 201931 Mar 2021

First posted7 Aug 2018
Study start14 Jan 2019
Primary completion30 Mar 2021
Study completion31 Mar 2021

Why it stopped: Investigational Medical Device is no longer available

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Non-randomised
Intervention model: Single group
Model description: Evaluation of Lotus Edge to treat patients with aortic stenosis. A single intervention is being evaluated in 3 study arms, the roll-in, main and bicuspid cohorts.
Masking: None (open label)
Enrolment: 382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03618095
Sponsor's protocol ID: S2354
Acronym: REPRISE IV
Status last verified: Oct 2022
First submitted: 1 Aug 2018
Last updated: 27 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
ClinicalTrials.gov ID: NCT03618095
Acronym / sponsor ID: REPRISE IV / S2354
Conditions: Aortic Valve Stenosis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Investigational Medical Device is no longer available
Enrolment: 382 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 14 Jan 2019 (actual)
Primary completion: 30 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 7 Aug 2018 (actual)
Results: Posted 27 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: Evaluation of Lotus Edge to treat patients with aortic stenosis. A single intervention is being evaluated in 3 study arms, the roll-in, main and bicuspid cohorts.

Arm	Type	Receives
Main Cohort	Experimental	Device: LOTUS Edge Valve SystemTranscatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
Roll-In Cohort	Experimental	Device: LOTUS Edge Valve SystemTranscatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
Bicuspid Cohort	Experimental	Device: LOTUS Edge Valve SystemTranscatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject has documented severe aortic stenosis defined as initial aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mm Hg OR maximal aortic valve velocity ≥4.0 m/s OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), 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. (IC1)
A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on computed tomography (CT) assessment and confirmed by the CT core lab with hemodynamic parameters that meet the criteria in IC1.
Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]).
Subject has symptomatic aortic valve stenosis per IC1 definition above with New York Heart Association (NYHA) Functional Class ≥ II.
Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality (≥3% and <8% at 30 days based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the risk calculator) and TAVR is appropriate. Note: Risk of operative mortality must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).

Key exclusion criteria (26 listed)

Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry cohort).
Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab. Subjects are not eligible for inclusion in the Bicuspid Nested Registry cohort if the maximum diameter of the ascending aorta is >45 mm or if the subject has another indication for aortic root replacement. Subjects with a Sievers Type 2 bicuspid valve are not eligible for enrollment in any study cohort.
Subject has had an acute myocardial infarction (MI) within 30 days prior to 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 creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
Subject is on renal replacement therapy or has Glomerular Filtration Rate (GFR) <20 (based on hospital preferred method). See AEC1 below if subject is in the CT Imaging Substudy.

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 SystemTAVR with the LOTUS Edge Valve System	Device	Bicuspid Cohort, Main Cohort, Roll-In Cohort

Primary outcome

Composite of All-cause Mortality and All Stroke.
Time frame: 1 year post index procedure and device implantation
Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC)

Results and safety

Results posted to the registry on 27 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Cohort	274	0
Roll-In Cohort	63	0
Bicuspid Cohort	45	0

Primary outcome: Composite of All-cause Mortality and All Stroke.

Time frame: 1 year post index procedure and device implantation. Count of participants. Unit: Participants

Measure	Main Cohort n = 174
Value	18

Population analysed: This study was terminated early. Enrollment was stopped before the target number of subjects were enrolled. Additionally, patient follow-up was terminated therefore, not all enrolled subjects at the time of termination were followed through the Primary Endpoint timepoint (1 Year). This analysis only represents those patients who reached 1 year at the time of study termination.

Adverse events

Time frame: Events collected through the Termination of the study, majority of patient an average of 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Cohort	175 of 274 (63.9%)	176 of 274 (64.2%)	14 of 274
Roll-In Cohort	42 of 63 (66.7%)	34 of 63 (54%)	8 of 63
Bicuspid Cohort	24 of 45 (53.3%)	35 of 45 (77.8%)	2 of 45

Limitations and caveats (from the sponsor): The study was terminated during enrollment and all follow-up of patients was also discontinued. As a result, the primary outcome is not representative of the full cohort of patients and represents a significantly smaller sample of patients to reach the 1 year timepoint in the Main cohort.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

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.

Christopher U. Meduri, MD, MPH principal investigator

Piedmont Heart Institute

Vinod H. Thourani, MD principal investigator

Piedmont Heart Institute

50 sites in 2 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 50 sites in 2 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 8 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: stopped early, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, 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 27 Dec 2022). 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?

Composite of All-cause Mortality and All Stroke. (time frame: 1 year post index procedure and device implantation). 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 NCT03618095.

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 27 Dec 2022.