A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System

NCT06147336 | Recruiting DMC FDA Device

• 1 other identifier: CLC-0035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 (2)

• LAP measurement

  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.

  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 six months post-procedure

Secondary Outcomes (8)

• Health Care Provider Usability Questionnaire

  Up to 24 months post-procedure

• Target LAP range

  Up to 24 months post-procedure

• New York Heart Association (NYHA) functional class

  Up to 24 months post-procedure

• Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall score

  Up to 24 months post-procedure

• Patient Global Assessment (PGA) Overall

  Up to 24 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, fixated within 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:

• 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 the 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.
• 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.
• 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) years old.
• Subjects who are NYHA class IV and ACC/AHA stage D.
• 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 at Baseline Visit.
• Left ventricular end-diastolic diameter (LVEDD) \> 8cm.
• 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 bpm).
• 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), or 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.
• 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 of implant procedure.
• Subjects not eligible for emergency open-heart, thoracic or vascular surgery.
• Women who are pregnant or planning to become pregnant.
• 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.

Sponsors & Collaborators

• Vectorious Medical Technologies Ltd.: lead

Study Sites (1)

One Boston Medical Center Place

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rami Kahwash, Prof.

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Ramesh Emani, Dr.

  Christ Hospital - Linder Research Institute

  PRINCIPAL INVESTIGATOR

• Sandip Zalawadiya, Dr.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Nir Ayalon, Dr.

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Michael DiVita, Dr.

  NYU Langone

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dedi Erdheim, Mr.

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: November 19, 2023
• First Posted: November 27, 2023
• Study Start: June 11, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)