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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01383720




Registration number
NCT01383720
Ethics application status
Date submitted
27/06/2011
Date registered
28/06/2011
Date last updated
20/06/2017

Titles & IDs
Public title
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
Scientific title
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
Secondary ID [1] 0 0
TP3659
Universal Trial Number (UTN)
Trial acronym
REPRISE I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Aortic Valve Calcification 0 0
Aortic Valve Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Lotus Valve System

Experimental: Lotus Valve System - Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis


Treatment: Devices: Lotus Valve System
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Discharge or 7 days post-procedure, whichever comes first
Secondary outcome [1] 0 0
Device Performance Endpoint-Repositioning - Successful repositioning of the Lotus Valve System if repositioning is attempted
Timepoint [1] 0 0
procedure
Secondary outcome [2] 0 0
Device Performance Endpoint-Valve Retrieval, if Attempted - Successful retrieval of the Lotus Valve System if retrieval is attempted
Timepoint [2] 0 0
procedure
Secondary outcome [3] 0 0
Central Aortic Regurgitation - As determined by echocardiography
Timepoint [3] 0 0
Discharge or 7 days post-procedure, whichever comes first
Secondary outcome [4] 0 0
Paravalvular Aortic Regurgitation - As determined by echocardiography
Timepoint [4] 0 0
Discharge or 7 days post-procedure, whichever comes first

Eligibility
Key inclusion criteria
1. Patient must be at least 70 years of age or older, and meets all of the criteria
below.

2. 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.

3. 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.

4. Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional
Class = II.

5. 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.

6. Patient (or legal representative) understands the trial requirements and the treatment
procedures, and provides written informed consent.

7. Patient agrees and is capable of returning to the study hospital for all required
scheduled follow up visits.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a congenital unicuspid or bicuspid aortic valve.

2. 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)).

3. 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.

4. Patient is on dialysis or has serum creatinine level >3.0 mg/dL.

5. Patient has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic
ring in any position.

6. Patient has >2+ mitral regurgitation or >2+ aortic regurgitation (ie., patient cannot
have more than moderate mitral or aortic regurgitation).

7. Moderate to severe pulmonary hypertension (PA systolic pressure >60 mm Hg) as assessed
by transthoracic echocardiography.

8. Patient has a need for emergency surgery for any reason.

9. Patient has a history of endocarditis within 12 months of index procedure or evidence
of an active systemic infection or sepsis.

10. Patient has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.

11. 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.

12. 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).

13. Patient has active peptic ulcer disease, gastrointestinal (GI) bleed within the past 3
months, other bleeding diathesis or coagulopathy or will refuse transfusions.

14. Patient is contraindicated for transesophageal echocardiography (TEE).

15. 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.

16. 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.

17. Patient has other cardiac devices or hardware with which the study device will
interfere with device placement (per physician judgment).

18. Patient has hypertrophic obstructive cardiomyopathy.

19. Patient has any therapeutic invasive cardiac procedure within 30 days prior to the
index procedure.

20. Untreated clinically significant coronary artery disease requiring revascularization.

21. Patient has documented left ventricular ejection fraction (LVEF) <30%.

22. Patient is in cardiogenic shock or has hemodynamic instability requiring inotropic
support or mechanical support devices.

23. 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.

24. 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.

25. Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc).

26. Patient is participating in another investigational drug or device study that has not
reached its primary endpoint.

27. Patient has preexisting untreated conduction system disorders: Type II second-degree
atrioventricular (AV) block, bifascicular or trifascicular block.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [3] 0 0
Southern Health Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3040 - Melbourne
Recruitment postcode(s) [3] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01383720
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, MBBS, PhD
Address 0 0
Southern Health, Monash Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications