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

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ClinicalTrials.gov Identifier: NCT03775161
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Vectorious Medical Technologies Ltd.

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: V-LAP™ System Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A First in Human Multi-center, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: V-LAP™ System
Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home
Device: V-LAP™ System
Delivery of the V-LAP™ implant via a catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.
Other Name: Echocardiography




Primary Outcome Measures :
  1. Usability of the Delivery System [ Time Frame: Intraoperative (Implantation) ]
    Ability to successfully deliver (to the interatrial septum) and deploy the V-LAP™ implant using the V-LAP™ delivery system.

  2. 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


Secondary Outcome Measures :
  1. Performance communication [ Time Frame: Up to three months post-procedure ]
    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

  2. Performance accuracy [ Time Frame: At index (baseline) and at three months ]
    LAP accuracy validation, concordance of the V-LAP implant measurement with pulmonary capillary wedge pressure (PCWP) measurement



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months.
  2. American College of Cardiology and the American Heart Association (ACC/AHA) Stage C, NYHA Class III or ambulatory Class IV HF documented at Baseline Visit.
  3. Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or European Society of Cardiology (ESC) Heart Failure Guidelines (guideline-directed medical therapy or GDMT).
  4. Receiving rhythm management device therapy as recommended by the ACC/AHA or ESC Guidelines.
  5. Have a minimum of one (1) prior hospital admission within the last 12-months for acute worsening of Heart Failure (HF) associated with signs/symptoms of congestion of at least one (1) calendar date. Alternatively, if patients have not had a HF hospitalization within the prior 12-months, they must have an 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.
  6. Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.

Exclusion Criteria:

  1. Age <18 or >85 years old.
  2. Patients who are NYHA class IV not ambulatory and ACC stage D.
  3. 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.
  4. 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.
  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 Patent Foramen Ovale (PFO) or Atrial Septal Defect (ASD) closure device and have a hypermobile septum or a septal aneurysm
  7. Patients with untreated severe valve lesions, which are indicated for surgical or percutaneous intervention, severe regurgitant (grade 4+) valve lesions
  8. Permanent atrial fibrillation, uncontrolled tachyarrhythmia or bradycardia (heart rate <45).
  9. Intolerant to diuretics, Angiotensin-converting enzyme inhibitors (ACEI) and Angiotensin Receptor Blocker (ARB) and beta-blocker medical therapy for patients classified as Reduced ejection fraction (HFrEF) (EF ≤40%).
  10. 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.
  11. Patients not eligible for emergency open-heart, thoracic or vascular surgery.
  12. Women of child bearing age
  13. 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.
  14. Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol
  15. Have an estimated glomerular filtration rate <30 ml/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) method or on dialysis.
  16. Hepatic impairment with at least one liver Function Test (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
  17. Gastrointestinal bleeding in the last 6 months
  18. 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 pulmonary function tests (PFTs) (forced expiration/forced vital capacity (FEV1/FVC <0.70 and FEV1 < 50% normal)).
  19. Patients who have an active infection requiring systemic antibiotics or an elevated white blood count (above the local laboratory reference ranges)
  20. Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
  21. Patient health questionnaire (PHQ-9) score ≥ 10
  22. Are currently participating in a clinical investigation that includes an active treatment arm.
  23. Subject otherwise not appropriate for study as determined by the investigator. The reasons must be documented.
  24. Patients contraindicated for trans-septal puncture, Transesophageal Echocardiography (TEE) or intracardiac ECHO (ICE).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775161


Contacts
Contact: Dedi Erdheim +972 72 342 5462 dedi@vectoriousmedtech.com

Locations
Germany
CardioVasculäres Centrum Frankfurt Recruiting
Frankfurt, Germany, 60389
Contact: Sabine de Bruijn    +49 69 9794 7653    s.debruijn@cvcfrankfurt.de   
Contact: Swati    +49 69 4600 3287    swati@cvcfrankfurt.de   
Sponsors and Collaborators
Vectorious Medical Technologies Ltd.
Investigators
Principal Investigator: 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

Responsible Party: Vectorious Medical Technologies Ltd.
ClinicalTrials.gov Identifier: NCT03775161     History of Changes
Other Study ID Numbers: CLC-0001
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases