Heart Failure
Conditions
Brief summary
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
Detailed description
The V- LAP™ System is intended for wirelessly measuring and monitoring LAP. The V-LAP™ System is indicated for subjects with chronic symptomatic ACC/AHA Stage C subjects Heart Failure. Pressure-guided medical management of study participants, with the goal of reducing hospitalizations and improving quality of life, will be implemented using a physician-directed patient self-management approach. V-LAP-PSM (Patient Self-management), Patient Guidance Application is a smartphone application that guides the patient on how to self-adjust the treatment, according to physician prescription, and when to approach their healthcare provider (HCP). Freedom from study (Device and/or system) related Major Adverse Cardiac and Neurological Events (MACNE as defined in the protocol) up to six months post-procedure, as adjudicated by the independent Clinical Events Committee.
Interventions
DEVICEV-LAP™ SYSTEM
Delivery of the V-LAP™ implant by right heart catheterization. A catheter-based approach in a trans-septal puncture procedure, fixated within the inter-atrial septum.
Sponsors
Vectorious Medical Technologies Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction. 2. NYHA Class II heart failure (HF) subjects, documented at Baseline Visit regardless of ejection fraction, meeting both inclusion criteria in subsections (2a) and (2b) or NYHA Class III heart failure (HF) subjects, documented at Baseline Visit regardless of ejection fraction, meeting at least one inclusion criteria in subsections (2a) and (2b). 1. Have a minimum of one (1) HF hospitalization or equivalent (HF Emergency Department Visit or HF Urgent Clinic Visit) within the last 12 months associated with signs/symptoms of congestion requiring treatment with intravenous (IV) diuretic. If Cardiac Resynchronization Therapy (CRT) device previously implanted, the HF hospitalization or equivalent must be ≥ 30 days after CRT implantation. 2. Have a corrected\* elevated outpatient Brain Natriuretic Peptide (BNP) level of at least 300 pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500 pg/ml, according to local measurement, within 90-days of the Baseline Visit. * Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 20 kg/m2. If the subject is on ARNI, NT-proBNP should be used exclusively. 3. Receiving maximally-tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT), in the absence of contraindications and lack of availability. GDMT refers to those guideline-directed medical therapies having a Class I indication for use. * For patient with heart failure and a reduced ejection fraction (HFrEF), GDMT includes a diuretic as needed for volume control, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor (ARNI), beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), and SGLT2 inhibitor for at least 3 months prior to the Baseline visit. Drug doses, with the exception of diuretics, should be stable for at least 1 month, where stability is defined as no more than a 100% increase or 50% decrease in dose. * For patient with heart failure and a preserved ejection fraction (HFpEF), GDMT includes a diuretic as needed for volume control and treatment of associated conditions (e.g., hypertension, atrial fibrillation) for at least 3 months prior to the Baseline visit. Drug doses, with the exception of diuretics, should be stable for at least 1 month, where stability is defined as no more than a 100% increase or 50% decrease in dose. * Patients should also receive Class I recommended cardiac rhythm management device therapy. Specifically: 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 Baseline Visit. 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. * GDMT may change over time; the most current versions of the ACC/AHA or ESC Heart Failure Guidelines will supersede the above guidelines. 4. Minimum technological knowledge of either the subject or the caregiver, with a smartphone or tablet for use of the self-management application, including physical ability and access to internet. 5. Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits. 6.5.2.
Exclusion criteria
Initial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint - Major Adverse Cardiac and Neurological Events (MACNE) | Up to six months post-procedure | Number of participants with study (Device and/ or system) related to Major Adverse Cardiac and Neurological Events (MACNE) - as defined in the protocol, as by the independent Clinical Events Committee |
| LAP measurement | Up to 12 months post-procedure | Freedom from failure of the V-LAP system to obtain LAP measurement from the sensor implant and transmit the LAP data to the V-LAPHCP HCP Interface and the V-LAPPSM Patient Guidance Application up to 12 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New York Heart Association (NYHA) functional class | Up to 24 months post-procedure | Change in NYHA functional class ranking at 6, 12, and 24 months vs. baseline. Stages of Heart Failure scoring 1-4 (1=High, 4=Low) |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall score | Up to 24 months post-procedure | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall score at 6, 12, and 24 months vs. baseline. Scores 1-7 (1=Minimum, 7=Maximum) |
| Patient Global Assessment (PGA) Overall | Up to 24 months post-procedure | Change in Patient Global Assessment (PGA) Overall score at 6, 12, and 24 months vs. baseline. Performance Score -3 - +3 (-3=Poor, +3=Excellent) |
| Health Care Provider Usability Questionnaire | Up to 24 months post-procedure | Usability assessment of the V-LAP system will be measured by questionnaires that will be completed by the investigator. Performance Score 1-5 (1=Poor, 5=Excellent) |
| Heart failure hospitalization duration | Up to 12months post-procedure | Heart failure hospitalization duration at 6 and 12 months (duration is calculated as number of days hospitalized over individual patient follow-up duration). |
| Usability Assessment - Patient Usability Questionnaire | Up to 24 months post-procedure | Usability assessment of the V-LAP system will be measured by questionnaires that will be completed by the patients. Performance Score 1-5 (1=Poor, 5=Excellent) |
| Heart failure hospitalization rate | Up to 12months post-procedure | Heart failure hospitalization rate at 6 and 12 months (rate is calculated as the number of hospitalizations over individual patient follow-up duration). |
| Target LAP range | Up to 24 months post-procedure | Ratio (percentage) of follow-up time in the target Left Atrial pressure (LAP) range as defined by the physician. |
Countries
United States
Contacts
Primary ContactDedi Erdheim, Mr.
Outcome results
None listed