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 (part of Johnson & Johnson) · 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).
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 16 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →V-Wave Ltd is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
First submitted before V-Wave Ltd became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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