Valtech - Clinical Results

Clinical Results

Clinical Trials

ONGOING –
Cardioband with transfemoral transseptal delivery system study is a single-arm, multi center study designed to evaluate the Cardioband implant in Europe. The primary endpoint was overall device-related safety at 30 days and technical success. Endpoints include hemodynamic measures by echocardiography (ECHO), mitral regurgitation reduction and functional improvement. Other key endpoints include assessments in functional status and quality of life.
CB1 – 1 – https://clinicaltrials.gov/ct2/show/NCT01533883?term=cardioband&rank=1

COMPLETED –
Cardioband with transatrial surgical delivery system feasibility study was a single-arm study designed to evaluate the Cardioband implant that enrolled five patients with mitral regurgitation in two centers in Europe. The primary endpoint was overall device-related safety at 30 days and technical feasibility. Endpoints include hemodynamic measures by echocardiography (ECHO) and mitral regurgitation reduction.
CB1 – 2 – https://clinicaltrials.gov/ct2/show/NCT01841554?term=cardioband&rank=2



91% Patients with MR ≤2+ At 12 Months by Core Lab

30% Average Reduction in Septo Lateral (A-P) Dimension

Septo-Lateral (A-P) Diameter (mm) Over Time