The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.
This is a prospective, single arm, multi-center study. A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Time frame: At 30 days
Number of Participants With Composite of Major Adverse Event (MAE)
Major Adverse Event (MAE) is defined as a composite of: * Cardiovascular Mortality * Myocardial Infarction (MI) * Stroke * New onset renal failure * Endocarditis requiring surgery, and * Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
Time frame: At 6 months
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Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mount Sinai Hospital
New York, New York, United States
Hospital Nord Laennec - Chu De Nantes
Nantes, Saint-Herblain, France
Bichat-Claude Bernard Hospital
Paris, France
Ludwig-Maximilian University of Munich (LMU)
Munich, Bavaria, Germany
Schuchtermann Klinik
Bad Rothenfelde, Lower Saxony, Germany
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
...and 10 more locations