REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
This trial is active, not recruiting.
|Condition||transcatheter aortic valve replacement|
|Treatment||lotus valve system|
|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|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Brisbane, Australia||Prince Charles Hospital||no longer recruiting|
|Melbourne, Australia||Monash Medical Center||no longer recruiting|
|Melbourne, Australia||St. Vincent's Hospital||no longer recruiting|
|Lyon, France||Hôpital Cardiologique de Lyon||no longer recruiting|
|Paris, France||Institut Cardiovasculaire Paris Sud||no longer recruiting|
|Toulouse, France||Centre Hôpital Universitaire Rangueil||no longer recruiting|
|Toulouse, France||Clinique Pasteur||no longer recruiting|
|Leipzig, Germany||Herzzentrum Universität Leipzig||no longer recruiting|
|München, Germany||Deutsches Herzzentrum München||no longer recruiting|
|Siegburg, Germany||Helios Klinikum Siegburg||no longer recruiting|
|Belfast, United Kingdom||Royal Victoria Hospital||no longer recruiting|
|Brighton, United Kingdom||Royal Sussex County Hospital||no longer recruiting|
|Leeds, United Kingdom||The General Infirmary||no longer recruiting|
|London, United Kingdom||Guys and St. Thomas NHS Foundation Trust||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Patients enrolled will receive the Lotus Valve.
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
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.
|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|
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