The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR. Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Bichat hospital
Paris, France
Bad Nauheim, Kerckhoff-Klinik
Bad Nauheim, Germany
Bonn University
Bonn, Germany
Koln, Universitätsklinikum
Cologne, Germany
Universitätsklinikum Gießen und Marburg
Giessen, Germany
University Hospital Halle (Saale)
Halle, Germany
Asklepios Klinik, St. Georg
Hamburg, Germany
Universitäres Herzzentrum Hamburg GmbH
Hamburg, Germany
Universitatsmedizin Mainz
Mainz, Germany
Hospital san raffaele
Milan, Italy
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Time frame: 30 days
Change in Distance Walked on 6 Minute Walk Test
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Time frame: 6 months over Baseline
Change in Mitral Regurgitation Severity
Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Time frame: 6, 12, and 24 months over baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.