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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
* bioprosthetic bovine pericardial aortic valve * delivery system
Royal Adelaide Hospital
Adelaide, Australia
Prince Charles Hospital
Brisbane, Australia
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.
Time frame: 30 days
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
Time frame: 30 days
Effective Orifice Area
Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)
Time frame: 30 days
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
Time frame: Post-procedure
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
Time frame: Post-procedure
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
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Monash Medical Center
Melbourne, Australia
St. Vincent's Hospital
Melbourne, Australia
Hôpital Cardiologique CHRU de Lille
Lille, France
Hôpital Cardiologique de Lyon
Lyon, France
Institut Cardiovasculaire Paris Sud
Paris, France
Centre Hôpital Universitaire Rangueil
Toulouse, France
Clinique Pasteur
Toulouse, France
Deutsches Herzzentrum München
München, Germany
...and 10 more locations
Time frame: Post-procedure
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)
Time frame: Post-procedure
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
Time frame: 30 days