An interventional study of Implantation of the V-Wave inter-atrial shunt in Congestive Heart Failure, sponsored by V-Wave Ltd. Completed at 6 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-07.
Sponsored by V-Wave Ltd · Not applicable, Interventional, and Device feasibility
The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.
V-Wave Ltd, an Israeli based medical device company, has developed the V-Wave atrial-septal shunt, a permanent implant indicated for Heart Failure (HF) patients with elevated Left Atrial filling Pressures (LAP). The V-Wave shunt, developed by V-Wave Ltd, has been designed specifically to meet the needs of an interatrial shunt and thus represents a dedicated device, to be implanted percutaneously in the interatrial septum creating an interatrial communication.
This study aims to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Heart Failure patients with elevated LAP. Study endpoints were then chosen to portray both safety (device related Major Adverse Cardiac And Neurological Events) as well as preliminary performance as assessed by a well characterized measure (e.g., LAP which is known to be associated with the general state of the disease and most importantly left ventricular ejection fraction and cardiac function in general).
Exclusion Criteria:
Implantation of the V-Wave inter-atrial shunt
Device: Implantation of the V-Wave inter-atrial shunt
Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach
Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation
MACNE is defined as the composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
Time frame: 3 month
Overall incidence of MACNE and Serious Adverse Device Events (SADEs) at 12 month post implantation
MACNE is defined as the composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
Time frame: 12 month
Reduction in Pulmonary Capillary Wedge Pressure (PCWP)
Reduction in PCWP as measured by Right Heart Catheterization (RHC) at 3 \& 12 month post implantation
Time frame: 3 and 12 month
Procedural success
Ability to successfully deliver (to the septal fossa ovalis) and deploy the V-Wave shunt
Time frame: Implantation procedure
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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V-Wave Ltd