Heart Failure, Mitral Regurgitation
Conditions
Brief summary
This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system.
Detailed description
The V-Wave Shunt is a device placed across the interatrial septum (IAS) by cardiac catheterization which allows for the transfer of blood from the left atrium (LA) to right atrium (RA). The intended effect is to reduce excessive left-sided cardiac filling pressures in patients with advanced heart failure (HF) and thus improve symptoms related to pulmonary congestion. All patients in the study must meet all anatomic and clinical eligibility in the FDA approved indications for use of the MitraClip in functional mitral regurgitation (MR). All patients must have persistence of New York Heart Association (NYHA) class III or ambulatory class IV HF symptoms despite maximally tolerated guideline directed medical therapy (GDMT) as assessed by a Cardiologist specialist in advanced heart failure (HF). All patients will have reduced left ventricular (LV) ejection fraction (EF) ≥ 20% and ≤ 50% and at least moderate to severe 3-4+ MR with a functional or combined functional and degenerative mechanism. Despite MitraClip treatment and maximum GDMT, these patients are at high risk for recurrent HF events and readmission, and thus there is an unmet need for further therapies to improve outcomes in this patient population. The existing transseptal puncture used for MitraClip placement will be used to place the V-Wave Shunt device after MitraClip placement.
Interventions
DEVICEV-Wave Shunt Placement
After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
Sponsors
samir kapadia
V-Wave Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. All patients must meet clinical and anatomic eligibility for commercial placement of MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU). a. Clinical eligibility for MitraClip: i. Symptomatic secondary MR (moderate-severe \[3+ or 4+\] or greater) due to ischemic or non-ischemic cardiomyopathy ii. NYHA functional class III, or ambulatory IV iii. Maximization of GDMT as directed by the "Heart Team", including an interventional cardiologist (implanting physician), heart failure cardiologist, and cardiothoracic surgeon. This includes adequate treatment for systolic HF (LV dysfunction), rhythm disorders, and coronary disease, if applicable 1. An inhibitor of the reninangiotensin system (RAS inhibitor), including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and a beta-blocker (BB) 2. Other medications recommended for selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate patients, according to the published guidelines. 3. Patient has been on stable HF medications as determined by the investigator, for at least 1 month, with the exception of diuretic therapy. Stable is defined as no more than a 100% increase or 50% decrease in dose within these periods. 4. Drug intolerance, contraindications, or lack of indications must be attested to by the investigator. 5. Receiving Class I recommended cardiac rhythm management device therapy. 1. If indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to device implantation 2. These criteria may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator. iv. At least one hospitalization for heart failure in last year OR corrected BNP ≥ 300 pg/mL or corrected NTproBNP ≥ 1500 pg/mL v. Heart team has determined that mitral valve (MV) surgery will not be offered as a treatment option b. Anatomic eligibility for MitraClip: i. LVEF ≥ 20% and ≤ 50% ii. LV end-systolic dimension ≤ 70 mm iii. MV orifice area \> 4.0 cm2 by TEE iv. Minimal calcification in the grasping area v. No leaflet cleft in the grasping area vi. In patients with a degenerative component to MR, the following additional criteria must be met: 1. Flail width \<15 mm 2. Flail gap \<10 mm vii. The primary regurgitant jet is non-commissural, and in the opinion of the implanting investigator can be successfully be treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant) viii. Transseptal catheterization and femoral vein access is feasible per investigator 2. Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.
Exclusion criteria
Preliminary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) | Up to1 month post implant | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSamir Kapadia, M. D.
The Cleveland Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Arrhythmia Disorders No | 2 Participants |
| Arrhythmia Disorders Yes | 8 Participants |
| Chronic Kidney Disease No | 4 Participants |
| Chronic Kidney Disease Yes | 6 Participants |
| Coronary Artery Disease No | 1 Participants |
| Coronary Artery Disease Yes | 9 Participants |
| Diabetes No | 5 Participants |
| Diabetes Yes | 5 Participants |
| Hyperlipidemia No | 1 Participants |
| Hyperlipidemia Yes | 9 Participants |
| Hypertension No | 2 Participants |
| Hypertension Yes | 8 Participants |
| Myocardial Infarction No | 2 Participants |
| Myocardial Infarction Yes | 8 Participants |
| Peripheral Artery Disease No | 8 Participants |
| Peripheral Artery Disease Yes | 2 Participants |
| Pulmonary Disease No | 5 Participants |
| Pulmonary Disease Yes | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
| Smoking Status Current Smoker | 2 Participants |
| Smoking Status Former Smoker | 6 Participants |
| Smoking Status Never Smoked | 2 Participants |
| Stroke No | 10 Participants |
| Stroke Yes | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 10 |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 9 / 10 |
Outcome results
None listed