This trial is active, not recruiting.

Condition transcatheter aortic valve replacement
Treatment lotus valve system
Phase phase 3
Sponsor Boston Scientific Corporation
Start date October 2012
End date April 2013
Trial size 120 participants
Trial identifier NCT01627691, TP3687


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients enrolled will receive the Lotus Valve.
lotus valve system
bioprosthetic bovine pericardial aortic valve delivery system

Primary Outcomes

Primary Device Performance Endpoint: Mean aortic valve pressure gradient at 30 days post implant procedure
time frame: 30 days
Primary Safety Endpoint: All-cause mortality at 30 days post implant procedure
time frame: 30 days

Eligibility Criteria

Male or female participants at least 70 years old.

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.

Additional Information

Official title REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
Principal investigator Ian Meredith, Professor
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.