Heart FailureVECTOR-HFNCT03775161
V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure
A study testing V-LAP™ System in people with Heart Failure, run by Vectorious Medical Technologies Ltd. at 2 sites in 2 countries.
Trial summary
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure. Read more about this study
- Who is it for?
- Ages 18 to 85 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
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jan 2019to Dec 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months.
- ACC/AHA Stage C, NYHA Class III or ambulatory Class IV HF documented at Baseline Visit.
- Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT), such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), beta-blocker (BB), and mineralocorticoid receptor blocker (MRB) for at least 3 months prior to the Baseline visit.
- Receiving rhythm management device therapy as recommended by the ACC/AHA or ESC Guidelines. Specifically: cardiac resynchronization therapy (CRT) should be implanted for at least 90 days prior to enrollment; an implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 30 days prior to enrollment. If subject is clinically contraindicated for these therapies this criterion may be waived.
- Have a minimum of one (1) prior hospital admission within the last 12-months for acute worsening of HF associated with signs/symptoms of congestion of at least one (1) calendar date change duration requiring treatment with an intravenous diuretic. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a HF hospitalization within the prior 12-months, they must have a corrected* elevated Brain Natriuretic Peptide (BNP) level of at least 300pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement, within 30-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 patient is on ARNI, NT-proBNP should be used exclusively.
- 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
- Age <18 or >85 years old.
- Patients who are NYHA class IV not ambulatory and ACC stage D.
- Patients with evidence/history of an intra-cardiac thrombus or history of stroke, transient ischemic attack, systemic or pulmonary thromboembolism, deep vein thrombosis (DVT), within the last 6 months.
- Patients with a resting systolic blood pressure <90 or >180 mmHg and/ or Severe pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram.
- 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
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- Patients with untreated severe valve lesions, which are indicated for surgical or percutaneous intervention, severe regurgitant (grade 4+) valve lesions, 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 cause of HF.
- Uncontrolled tachyarrhythmia or bradycardia (heart rate <45).
- Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D), including patients receiving continuous or intermittent outpatient IV vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD).
- Intolerant to diuretics, ACEI and ARB and beta-blocker medical therapy for patients 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.
- Patients not eligible for emergency open-heart, thoracic or vascular surgery.
- Women of childbearing age
- Patients 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.
- Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol
- Have an estimated glomerular filtration rate <25 ml/min/1.73 m2 by the MDRD method or on 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
- 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).
- Patients 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.
- Are currently participating in a clinical investigation that includes an active treatment arm.
- Subject otherwise not appropriate for study as determined by the investigator. The reasons must be documented.
- Patients 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 trans-septal puncture)
- 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.
- Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate an RHC.
- Hemodynamic at time of Index Procedure including: Severe pulmonary hypertension defined as PASP>70 mmHg or PVR >4.0 Woods Units (mmHg L-1 min-1); Resting systolic Blood Pressure <90 or >180 mmHg, not corrected with IV fluid administration or vasodilators, respectively.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A First in Human Multi-center, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
Read the detailed description
The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the interatrial septum, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 3 month follow up visit. 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
Also called Echocardiography
Delivery of the V-LAP™ implant via 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 | Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home Receives: Device: V-LAP™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the Delivery System
Ability to successfully deliver (to the interatrial septum) and deploy the V-LAPIM using the V-LAPDL and acutely perform initial pressure measurement.
Measured: Intraoperative (Implantation)
Safety Endpoint: Study (Device and/ or system) related 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
Secondary outcomes (3)
Performance communication
Freedom from failure of the V-LAP system to obtain the left atrial pressure (LAP) measurement from the sensory implant and transmit the LAP data to the V-LAP Data Display
Measured: Up to three months post-procedure
Performance accuracy
LAP accuracy validation, concordance of the V-LAP implant measurement with pulmonary capillary wedge pressure (PCWP) measurement
Measured: At index (baseline) and at three months
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start8 Jan 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vectorious Medical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, Prof. Dr., Principal investigator, Director and Founder of CardioVasculäres Centrum FrankfurtCarlo Di Mario, Professor, Principal investigator, University of Florence and Careggi University HospitalFrancisco Leyva, Professor, Principal investigator, Consultant Cardiologist, Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775161
- Sponsor's protocol ID
- CLC-0001
- Acronym
- VECTOR-HF
- Status last verified
- May 2025
- First submitted
- 10 Dec 2018
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Amario D, Meerkin D, Restivo A, Ince H, Sievert H, Wiese A, Schaefer U, Trani C, Bayes-Genis A, Leyva F, Whinnett ZI, Di Mario C, Jonas M, Manhal H, Amat-Santos IJ, Del Trigo M, Gal TB, Avraham BB, Hasin T, Feickert S, D'Ancona G, Altisent OA, Koren O, Caspi O, Abraham WT, Crea F, Anker SD, Kornowski R, Perl L; VECTOR-HF Trial Investigators. Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial. Eur J Heart Fail. 2023 Jun;25(6):902-911. doi: 10.1002/ejhf.2869. Epub 2023 May 10.
PubMed 37092287D Ancona G, Murero M, Feickert S, Kaplan H, Oner A, Ortak J, Ince H. Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients' Attitudes. JMIR Cardio. 2021 Apr 21;5(1):e21055. doi: 10.2196/21055.
PubMed 33881400D'Amario D, Restivo A, Canonico F, Rodolico D, Mattia G, Francesco B, Vergallo R, Trani C, Aspromonte N, Crea F. Experience of remote cardiac care during the COVID-19 pandemic: the V-LAP device in advanced heart failure. Eur J Heart Fail. 2020 Jun;22(6):1050-1052. doi: 10.1002/ejhf.1900. Epub 2020 Jun 26. No abstract available.
PubMed 32431021
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 First in Human Multi-center, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System
- ClinicalTrials.gov ID
- NCT03775161
- Acronym / sponsor ID
- VECTOR-HF / CLC-0001
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Vectorious Medical Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Dec 2018 (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 purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
Detailed description
The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the interatrial septum, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 3 month follow up visit. 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™ SystemPercutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months.
- ACC/AHA Stage C, NYHA Class III or ambulatory Class IV HF documented at Baseline Visit.
- Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT), such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), beta-blocker (BB), and mineralocorticoid receptor blocker (MRB) for at least 3 months prior to the Baseline visit.
- Receiving rhythm management device therapy as recommended by the ACC/AHA or ESC Guidelines. Specifically: cardiac resynchronization therapy (CRT) should be implanted for at least 90 days prior to enrollment; an implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 30 days prior to enrollment. If subject is clinically contraindicated for these therapies this criterion may be waived.
- Have a minimum of one (1) prior hospital admission within the last 12-months for acute worsening of HF associated with signs/symptoms of congestion of at least one (1) calendar date change duration requiring treatment with an intravenous diuretic. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a HF hospitalization within the prior 12-months, they must have a corrected* elevated Brain Natriuretic Peptide (BNP) level of at least 300pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement, within 30-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 patient is on ARNI, NT-proBNP should be used exclusively.
Key exclusion criteria (29 listed)
- Age <18 or >85 years old.
- Patients who are NYHA class IV not ambulatory and ACC stage D.
- Patients with evidence/history of an intra-cardiac thrombus or history of stroke, transient ischemic attack, systemic or pulmonary thromboembolism, deep vein thrombosis (DVT), within the last 6 months.
- Patients with a resting systolic blood pressure <90 or >180 mmHg and/ or Severe pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram.
- Left ventricular end-diastolic diameter (LVEDD) > 8cm.
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™ SystemAlso: EchocardiographyDelivery of the V-LAP™ implant via a catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum. | Device | V-LAP™ System |
Primary outcome
Usability of the Delivery System
Time frame: Intraoperative (Implantation)
Ability to successfully deliver (to the interatrial septum) and deploy the V-LAPIM using the V-LAPDL and acutely perform initial pressure measurement.
Safety Endpoint: Study (Device and/ or system) related Major Adverse Cardiac and Neurological Events (MACNE)
Time frame: Up to three months post-procedure
(as defined in the protocol), as by the independent Clinical Events Committee
3 secondary outcomes
Performance communication
Time frame: Up to three months post-procedure
Performance accuracy
Time frame: At index (baseline) and at three months
Usability Assessment
Time frame: Up to 24 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.
- Derived from this study: PubMed 37092287D'Amario D, Meerkin D, Restivo A, Ince H, Sievert H, Wiese A, Schaefer U, Trani C, Bayes-Genis A, Leyva F, Whinnett ZI, Di Mario C, Jonas M, Manhal H, Amat-Santos IJ, Del Trigo M, Gal TB, Avraham BB, Hasin T, Feickert S, D'Ancona G, Altisent OA, Koren O, Caspi O, Abraham WT, Crea F, Anker SD, Kornowski R, Perl L; VECTOR-HF Trial Investigators. Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial. Eur J Heart Fail. 2023 Jun;25(6):902-911. doi: 10.1002/ejhf.2869. Epub 2023 May 10.
- Derived from this study: PubMed 33881400D Ancona G, Murero M, Feickert S, Kaplan H, Oner A, Ortak J, Ince H. Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients' Attitudes. JMIR Cardio. 2021 Apr 21;5(1):e21055. doi: 10.2196/21055.
- Derived from this study: PubMed 32431021D'Amario D, Restivo A, Canonico F, Rodolico D, Mattia G, Francesco B, Vergallo R, Trani C, Aspromonte N, Crea F. Experience of remote cardiac care during the COVID-19 pandemic: the V-LAP device in advanced heart failure. Eur J Heart Fail. 2020 Jun;22(6):1050-1052. doi: 10.1002/ejhf.1900. Epub 2020 Jun 26. No abstract available.
- 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. This study is not recruiting at the moment.
Horst Sievert, Prof. Dr. principal investigator
Director and Founder of CardioVasculäres Centrum Frankfurt
Carlo Di Mario, Professor principal investigator
University of Florence and Careggi University Hospital
Francisco Leyva, Professor principal investigator
Consultant Cardiologist, Queen Elizabeth Hospital
2 sites in 2 countries: 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 2 sites in 2 countries.
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 7 inclusion and 29 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: under way, not looking for participants, 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 2 sites in Germany, Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Delivery System (time frame: Intraoperative (Implantation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775161, which also lists 3 linked publications.
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.