V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure

NCT03775161 | Active Not Recruiting

• 1 other identifier: CLC-0001
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Up to three months post-procedure

Secondary Outcomes (3)

• Performance communication

  Up to three months post-procedure

• Performance accuracy

  At index (baseline) and at three months

• Usability Assessment

  Up to 24 months post procedure

Other Outcomes (3)

• NYHA functional class

  Up to 24 months post procedure

• KCCQ score

  Up to 24 months post procedure

• Heart failure hospitalization rate

  Up to 60 months post procedure

Study Arms (1)

V-LAP™ System

EXPERIMENTAL

Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home

Device: V-LAP™ System

Interventions

V-LAP™ System DEVICE

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

Also known as: Echocardiography

V-LAP™ System

Eligibility Criteria

• Age: 18 Years - 85 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vectorious Medical Technologies Ltd.: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (2)

CardioVasculäres Centrum Frankfurt

Frankfurt, 60389, Germany

Location

Careggi University Hospital Trust

Florence, 50134, Italy

Location

Related Publications (3)

• 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.

  PMID: 37092287 DERIVED

• D 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.

  PMID: 33881400 DERIVED

• D'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.

  PMID: 32431021 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Horst Sievert, Prof. Dr.

  Director and Founder of CardioVasculäres Centrum Frankfurt

  PRINCIPAL INVESTIGATOR

• Carlo Di Mario, Professor

  University of Florence and Careggi University Hospital

  PRINCIPAL INVESTIGATOR

• Francisco Leyva, Professor

  Consultant Cardiologist, Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

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: December 10, 2018
• First Posted: December 13, 2018
• Study Start: January 8, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (1)