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Conditions studied

Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Regurgitation

What it measures

• PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs)., 30 days.
• PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort., 6 months
• PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only., From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up

Conditions studied

Cardiovascular Diseases, Mitral Regurgitation Functional, Mitral Valve Disease

What it measures

• Primary Safety Endpoint, The composite (aggregate) of the following implant-related and/or delivery-related serious adverse events (SAEs) at 30 days post index procedure (based on MVARC definitions and adjudicated by an independent clinical events committee). The unit of outcome measure is % (n/N): * Mortality: all-cause * Stroke: disabling and non-disabling; Bleeding: life-threatening based MVARC scale * Major access site vascular complications * Major cardiac structural complications due to access-related issues * Acute kidney injury (AKI; ≤7 days post index procedure): based on the Acute Kidney Injury Network (AKIN) --System Stage 3 (including renal replacement therapy) or Stage 2 * Myocardial infarction (MI; periprocedural \[≤48 hours\] or spontaneous \[\>48 hours\]) * Coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post index procedure
• Primary Technical Success Endpoint, Technical Success (measured at exit from the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC ). All of the following must be present: Absence of procedural mortality; and Successful access, delivery and retrieval of the device delivery system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure., Index procedure exit from the catheterization laboratory

Conditions studied

Cardiovascular Diseases, Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Heart Valve Diseases, Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Insufficiency, Valve Disease, Heart

What it measures

• Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH), The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%., 12 months post index procedure

Conditions studied

Mitral Valve Regurgitation (Degenerative or Functional)

What it measures

• Composite of major adverse events, Proportion of patients with major adverse events, 30 days

Conditions studied

Mitral Valve Regurgitation

What it measures

• All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded), The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively, 2 Years
• Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous), Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively, 2 Years

Conditions studied

Mitral Valve Regurgitation

What it measures

• All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score., All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention. Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean., 3 years post intervention

Working with

National Heart, Lung, and Blood Institute (NHLBI)

Conditions studied

Mitral Disease, Mitral Regurgitation

What it measures

• Technical Success, Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure, At the end of the procedure

Conditions studied

Mitral Valve Insufficiency

What it measures

• Percent of Subjects With Adverse Events, PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure, 30 days

Conditions studied

Mitral Regurgitation

What it measures

• Change in NYHA classification from Baseline to 5 years, The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest., Baseline compared to 1 and 5 years

Conditions studied

Heart Failure, Mitral Regurgitation

What it measures

• Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE), Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery, Up to1 month post implant

Working with

V-Wave Ltd