Heart FailureNCT05712824
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF
A study testing V-LAP™ SYSTEM in people with Heart Failure, run by Vectorious Medical Technologies Ltd. at 3 sites in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 88 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- V-LAP™ SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesGeorgia
- Study dates
- 20 Dec 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction.
- 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).
- 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.
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- 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.
Who cannot join
- 1. 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.
- 4. 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.
- 7. 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.
- 8. 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).
- 10. Intolerant to ACE-I, ARB, or ARNI and beta-blocker medical therapy for subjects classified as HFrEF (EF ≤40%).
- 11. 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.
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- 12. Subjects not eligible for emergency open-heart, thoracic or vascular surgery.
- 13. 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.
- 15. Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.
- 16. Known history of life-threatening allergy to contrast dye that cannot be properly pre-medicated.
- 17. Have an estimated Glomerular Filtration Rate (GFR) <20 ml/min/1.73 m2 by the MDRD method or on chronic renal dialysis.
- 18. Hepatic impairment with at least one liver Function Test (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
- 19. 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.
- 21. Subjects who have an active infection requiring systemic antibiotics or an elevated white blood count (above the local laboratory reference ranges).
- 22. Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
- 23. Are currently participating in a clinical study or investigation. 24. Subject otherwise not appropriate for study as determined by the investigator and subjects who are unwilling to comply with the study protocol, or subjects with a history of non-compliance. The reasons must be documented.
- 25. Subjects contraindicated for trans-septal puncture, TEE or ICE.
- Intra Procedural Exclusion Criteria:
- (Intra Procedural Exclusion Criteria will be determined immediately after intracardiac echocardiography or transesophageal echocardiography determination of left atrial anatomy and just before transseptal puncture) 26. Anatomical anomaly on TEE or ICE that precludes implantation of the V-LAPIM across the interatrial septum (Fossa Ovalis) including: Septal thickness at fossa > 5 mm, FO Dimension <16mm, ASD or PFO with more than a trace amount of shunting, intra-cardiac thrombus felt to be acute and not present on prior exams and abnormal septum, e.g., a hypermobile septum or a septal aneurysm.
- 27. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate a right heart catheterization (RHC).
- 28. Severe pulmonary hypertension at index procedure above 70 mmHg or PVR at index procedure above 4.0 Woods Units (mmHg L-1 min-1), while these cannot be lowered with vasodilators.
- 29. Resting systolic Blood Pressure <90 or >180 mmHg, not corrected with IV fluid administration or vasodilators.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia3 sites, 3 recruiting
- Recruiting
Aleksandre Aladashvili Clinic
Tbilisi, Georgia
Shalva Petriashvili, Dr., +995 599147292, ana_givi@yahoo.com
- Recruiting
Jerarsi Clinic
Tbilisi, Georgia
Mikheil Metreveli, Prof., +995 0322111112, michaelmetreveli@yahoo.com
- Recruiting
Tbilisi Medical Institute- TIM
Tbilisi, Georgia
Levan Kurashvili, Dr., +995 322900001, info@tim.ge
About this study
Official title: A Multi-center, Open-label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System
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.
Read the detailed description
The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the interatrial septum.
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.
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 the study investigator.
Safety will be monitored by the occurrence of adverse events throughout the trial.
- Conditions
- Heart Failure
- Being tested
- V-LAP™ SYSTEM
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-LAP™ SYSTEMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: V-LAP™ SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Up to 24 months post-procedure
Secondary outcomes (5)
Target LAP range
Ratio (%) of follow-up time in the target LAP range as defined by the physician.
Measured: Up to 12 months post-procedure
NYHA functional class
Change in NYHA functional class ranking at 6, 12, and 24 months vs. baseline.
Measured: Up to 24 months post-procedure
KCCQ Overall score
Change in KCCQ Overall score at 6, 12, and 24 months vs. baseline.
Measured: Up to 24 months post-procedure
PGA Overall
Change in PGA Overall score at 6, 12 and 24 months vs. baseline.
Measured: Up to 24 months post-procedure
Heart failure hospitalization rate
Heart failure hospitalization rate at 6 and 12 months (rate is calculated as the number of hospitalizations over individual patient follow-up duration).
Measured: Up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start20 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vectorious Medical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712824
- Sponsor's protocol ID
- CLC-0022
- Status last verified
- May 2025
- First submitted
- 25 Jan 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System
- ClinicalTrials.gov ID
- NCT05712824
- Acronym / sponsor ID
- CLC-0022
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vectorious Medical Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 trial is designed to demonstrate that the V-LAP™ implant can be positioned in the interatrial septum.
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.
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 the study investigator.
Safety will be monitored by the occurrence of adverse events throughout the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-LAP™ System | Experimental | Device: V-LAP™ SYSTEMHeart 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. |
Who may qualify
- Ages
- 22 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General Inclusion Criteria:
Key exclusion criteria (22 listed)
- 1. 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.
- 4. 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.
- 7. 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.
- 8. 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).
- 10. Intolerant to ACE-I, ARB, or ARNI and beta-blocker medical therapy for subjects classified as HFrEF (EF ≤40%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-LAP™ SYSTEMDelivery 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. | Device | V-LAP™ System |
Primary outcome
LAP measurement
Time frame: Up to 12 months post-procedure
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.
Safety Endpoint - Major Adverse Cardiac and Neurological Events (MACNE)
Time frame: Up to three 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
Usability Assessment
Time frame: 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, patient, and medical team
5 secondary outcomes
Target LAP range
Time frame: Up to 12 months post-procedure
NYHA functional class
Time frame: Up to 24 months post-procedure
KCCQ Overall score
Time frame: Up to 24 months post-procedure
PGA Overall
Time frame: Up to 24 months post-procedure
Heart failure hospitalization rate
Time frame: Up to 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-LAP™ SYSTEM in people with Heart Failure, run by Vectorious Medical Technologies Ltd. at 3 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dedi Erdheim (+972 72 342 5462, dedi@vectoriousmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LAP measurement (time frame: Up to 12 months post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.