REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Transcatheter Aortic Valve Replacement
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 250
- Locations
- 20
- Primary Endpoint
- Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
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.
Outcomes
Primary Outcomes
Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
Time Frame: 30 days
Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure
Time Frame: 30 days
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
Secondary Outcomes
- Device Success According to the Valve Academic Research Consortium (VARC)(Post-procedure)
- Device Performance Endpoint: Successful Vascular Access(Post-procedure)
- Effective Orifice Area(30 days)
- Device Performance Endpoint: Successful Retrieval(Post-procedure)
- Grade of Aortic Valve Regurgitation(30 days)
- Device Performance Endpoint: Successful Repositioning(Post-procedure)