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V-LAP™ System for Heart Failure

This study is testing a device called the V-LAP™ System for people with heart failure. The V-LAP™ System is a small device that is placed in your heart using a catheter (a thin tube) during a procedure. It's designed to wirelessly measure and monitor pressures in your heart. The goal is to see how safe and effective the V-LAP™ System is at reducing hospital stays and improving your quality of life. You might be able to join if you are 22 to 88 years old and have had heart failure for at least 6 months, with NYHA Class II or III heart failure (meaning you have some limitations due to your heart condition). The study will look at heart pressure measurements for up to 12 months and major heart and brain-related events for up to six months after the procedure. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving the V-LAP™ System. It plans to enroll 10 participants.
What's involved
You will have the V-LAP™ System implanted and will use a smartphone app to help manage your treatment. Your heart pressure will be measured for up to 12 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 12 months to measure heart pressure and for up to six months to monitor for major heart and brain-related events.

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NCT06147336

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

Recruiting
NAAges 22–88InterventionalDiagnostic
Vectorious Medical Technologies Ltd.
~10 participants
Updated 2025-05-30 on ClinicalTrials.gov
What's tested:V-LAP™ SYSTEM

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
LAP measurement
Measured over Up to 12 months post-procedure
+1 more outcome measured

Conditions

Heart Failure

Explore related trials

Heart FailureNPPB wt AlleleN-Terminal Fragment Brain Natriuretic Protein

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Rami Kahwash, Prof. · PRINCIPAL_INVESTIGATOR · Ohio State University
  • Ramesh Emani, Dr. · PRINCIPAL_INVESTIGATOR · Christ Hospital - Linder Research Institute
  • Sandip Zalawadiya, Dr. · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
  • Nir Ayalon, Dr. · PRINCIPAL_INVESTIGATOR · Boston Medical Center
  • Michael DiVita, Dr. · PRINCIPAL_INVESTIGATOR · NYU Langone

Who to contact

Dedi Erdheim, Mr.
[email protected]
+972 72 342 5462
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • LAP measurementUp 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.

  • 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