V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF

NCT05712824 | Recruiting DMC

• 1 other identifier: CLC-0022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• LAP measurement

  Freedom from the 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.

  Up to 12 months post-procedure

• Safety Endpoint - Major Adverse Cardiac and Neurological Events (MACNE)

  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

  Up to three months post-procedure

• Usability Assessment

  Usability Assessment of the V-LAP system will be measured by questionnaires that will be completed by the investigator, patient, and medical team

  Up to 24 months post-procedure

Secondary Outcomes (5)

• Target LAP range

  Up to 12 months post-procedure

• NYHA functional class

  Up to 24 months post-procedure

• KCCQ Overall score

  Up to 24 months post-procedure

• PGA Overall

  Up to 24 months post-procedure

• Heart failure hospitalization rate

  Up to 12 months post-procedure

Study Arms (1)

V-LAP™ System

EXPERIMENTAL

Heart failure subjects - Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home and will be trained on the use of the device for self-management.

Device: V-LAP™ SYSTEM

Interventions

V-LAP™ SYSTEM DEVICE

Delivery of the V-LAP™ implant by right heart catheterization. A catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.

V-LAP™ System

Eligibility Criteria

• Age: 22 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction.
• 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.
• 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 subject is on ARNI, NT-proBNP should be used exclusively.
• 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.
• Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions, and follow-up visits.

You may not qualify if:

• \. Age less than 22 (\<22) or greater than 88 (\>88) years old. 2. Subjects who are NYHA class IV and ACC/AHA stage D. 3. Subjects with evidence/history of a major cardiovascular or neurovascular event, such as an intra-cardiac thrombus or history of stroke, transient ischemic attack, systemic or pulmonary thromboembolism, deep vein thrombosis (DVT), within the last 6 months of Baseline Visit.
• \. Subjects with a resting systolic blood pressure \<90 or \>180 mmHg. 5. Left ventricular end-diastolic diameter (LVEDD) \> 8cm. 6. Have an atrial septal defect or patent foramen ovale with more than trace shunting on color Doppler or intravenous bubble study or surgical or interventional correction of congenital heart disease involving atrial septum, including placement of a PFO or ASD closure device, and have a hypermobile septum or a septal aneurysm.
• \. Subjects with untreated severe valve lesions, which are indicated for surgical or percutaneous intervention, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as a cause of HF.
• \. Uncontrolled tachyarrhythmia or bradycardia (heart rate \<45). 9. Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D), including subjects receiving continuous or intermittent outpatient IV vasoactive medications (e.g., IV inotropes, IV vasodilators), subjects treated with a ventricular assist device (VAD).
• \. Intolerant to ACE-I, ARB, or ARNI and beta-blocker medical therapy for subjects classified as HFrEF (EF ≤40%).
• \. The presence of an acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), rhythm management system revision, lead extraction, or cardiac or other major surgery within the preceding 90 days.
• \. Subjects not eligible for emergency open-heart, thoracic or vascular surgery.
• \. Women of childbearing age. 14. Subjects with a life expectancy that is shorter than 12 months, or those who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months of Baseline Visit.
• \. Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.
• \. Known history of life-threatening allergy to contrast dye that cannot be properly pre-medicated.
• \. Have an estimated Glomerular Filtration Rate (GFR) \<20 ml/min/1.73 m2 by the MDRD method or on chronic renal dialysis.
• \. Hepatic impairment with at least one liver Function Test (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
• \. Gastrointestinal bleeding in the last 6 months. 20. Have severe chronic pulmonary disease requiring continuous home oxygen, chronic oral steroid therapy, hospitalization for exacerbation during prior 6 months, or has severe obstructive physiology on PFTs (FEV1/FVC \<0.70 and FEV1 \< 50% normal), if done.
• \. Subjects who have an active infection requiring systemic antibiotics or an elevated white blood count (above the local laboratory reference ranges).
• \. Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.

Sponsors & Collaborators

• Vectorious Medical Technologies Ltd.: lead

Study Sites (3)

Aleksandre Aladashvili Clinic

Tbilisi, Georgia, Georgia

RECRUITING

Jerarsi Clinic

Tbilisi, Georgia, Georgia

RECRUITING

Tbilisi Medical Institute- TIM

Tbilisi, Georgia, Georgia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Dedi Erdheim

CONTACT

+972 72 342 5462; dedi@vectoriousmedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: December 20, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GE (3)