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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01627691




Registration number
NCT01627691
Ethics application status
Date submitted
5/06/2012
Date registered
26/06/2012
Date last updated
12/05/2020

Titles & IDs
Public title
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
Scientific title
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
Secondary ID [1] 0 0
TP3687
Secondary ID [2] 0 0
TP3687
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transcatheter Aortic Valve Replacement 0 0
Condition category
Condition code

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

Experimental: Lotus Valve System - Patients enrolled will receive the Lotus Valve.


Treatment: Devices: Lotus Valve System
bioprosthetic bovine pericardial aortic valve
delivery system

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

Outcomes
Primary outcome [1] 0 0
Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure - Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure - Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Effective Orifice Area - Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Device Performance Endpoint: Successful Vascular Access - Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site
Timepoint [2] 0 0
Post-procedure
Secondary outcome [3] 0 0
Device Performance Endpoint: Successful Retrieval - Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site
Timepoint [3] 0 0
Post-procedure
Secondary outcome [4] 0 0
Device Performance Endpoint: Successful Repositioning - Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site
Timepoint [4] 0 0
Post-procedure
Secondary outcome [5] 0 0
Device Success According to the Valve Academic Research Consortium (VARC) - Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)
Timepoint [5] 0 0
Post-procedure
Secondary outcome [6] 0 0
Grade of Aortic Valve Regurgitation - Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory
Timepoint [6] 0 0
30 days

Eligibility
Key inclusion criteria
- Subject is =70 years of age

- Subject has documented calcific native aortic valve stenosis

- Subject has a documented aortic annulus size between =19 and =27 mm based on
pre-procedure diagnostic imaging

- Symptomatic aortic valve stenosis with NYHA Functional Class = II

- Subject is considered high risk for surgical valve replacement

- Heart team 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.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has a congenital unicuspid or bicuspid aortic valve.

- Subject with an acute myocardial infarction within 30 days of the index procedure

- 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 cannot have more than moderate mitral, aortic or tricuspid regurgitation

- 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 low Hgb, platelet count or >700,000 cells/mm3, or low white blood cell
count.

- Subject requires chronic anticoagulation therapy and cannot tolerate concomitant
therapy with either aspirin or clopidogrel/ticlopidine

- 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 within 30 days prior to the
index procedure (except for pacemaker implantation which is allowed).

- Subject has untreated coronary artery disease.

- 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 or symptomatic carotid or vertebral
disease.

- Narrow Femoral artery lumen precludes the use of either Lotus device 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.

- Patient has preexisting untreated conduction system disorder that requires new
pacemaker implantation.

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)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Monash Medical Center - Melbourne
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lille
Country [2] 0 0
France
State/province [2] 0 0
Lyon
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
France
State/province [4] 0 0
Toulouse
Country [5] 0 0
Germany
State/province [5] 0 0
München
Country [6] 0 0
Germany
State/province [6] 0 0
Siegburg
Country [7] 0 0
Italy
State/province [7] 0 0
Catania
Country [8] 0 0
Netherlands
State/province [8] 0 0
Rotterdam
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Sweden
State/province [10] 0 0
Lund
Country [11] 0 0
Switzerland
State/province [11] 0 0
Bern
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Belfast
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Brighton
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Leeds
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve
System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe
calcific aortic stenosis who are considered high risk for surgical valve replacement.
Trial website
https://clinicaltrials.gov/show/NCT01627691
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicolas Dumonteil, MD
Address 0 0
Clinique Pasteur
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