Clinical trial NCT01627691: REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
Official title: REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 250
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
timeFrame: 30 days
measure: Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure
timeFrame: 30 days
Secondary outcomes:
measure: Effective Orifice Area
timeFrame: 30 days
measure: Device Performance Endpoint: Successful Vascular Access
timeFrame: Post-procedure
measure: Device Performance Endpoint: Successful Retrieval
timeFrame: Post-procedure
measure: Device Performance Endpoint: Successful Repositioning
timeFrame: Post-procedure
measure: Device Success According to the Valve Academic Research Consortium (VARC)
timeFrame: Post-procedure
measure: Grade of Aortic Valve Regurgitation
timeFrame: 30 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Brisbane
country: Australia
facility: Prince Charles Hospital
city: Melbourne
country: Australia
facility: Monash Medical Center
city: Melbourne
country: Australia
facility: St. Vincent's Hospital
city: Lille
country: France
facility: Hôpital Cardiologique CHRU de Lille
city: Lyon
country: France
facility: Hôpital Cardiologique de Lyon
city: Paris
country: France
facility: Institut Cardiovasculaire Paris Sud
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thorax Center
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Lund
country: Sweden
facility: University Hospital of Lund
city: Bern
country: Switzerland
facility: INSELSPITAL - Universitätsspital Bern
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leeds
country: United Kingdom
facility: The General Infirmary
city: London
country: United Kingdom
facility: Guys and St. Thomas NHS Foundation Trust
Study officials:
affiliation: Clinique Pasteur
name: Nicolas Dumonteil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meredith IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Feldman TE, Allocco DJ, Dawkins KD. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.
citation: Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014 Sep 30;64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.