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V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance Chronic Heart Failure

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
V-LAP™ SYSTEM
Sponsored by
Vectorious Medical Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

22 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction.

2. 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).

  1. 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.
  2. 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.

    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. 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 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.

      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.

Sites / Locations

  • Rabin Belinson, Medical Center - IsraelRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V-LAP™ System

Arm Description

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.

Outcomes

Primary Outcome Measures

LAP measurement
Freedom from failure of the V-LAP system to obtain LAP measurement from the sensor implant and transmit the LAP data to the V-LAPDD Data Display and the V-LAPPSM Patient Guidance Application.
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
Performance accuracy
LAP accuracy validation, concordance of the V-LAP implant measurement with pulmonary capillary wedge pressure (PCWP) measurement

Secondary Outcome Measures

Full Information

First Posted
June 26, 2022
Last Updated
August 14, 2023
Sponsor
Vectorious Medical Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05448833
Brief Title
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance Chronic Heart Failure
Official Title
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (Lap) In Patients With Advanced Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vectorious Medical Technologies Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V-LAP™ System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
V-LAP™ SYSTEM
Intervention Description
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.
Primary Outcome Measure Information:
Title
LAP measurement
Description
Freedom from failure of the V-LAP system to obtain LAP measurement from the sensor implant and transmit the LAP data to the V-LAPDD Data Display and the V-LAPPSM Patient Guidance Application.
Time Frame
Up to 12 months post-procedure
Title
Safety Endpoint - Major Adverse Cardiac and Neurological Events (MACNE)
Description
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
Time Frame
Up to three months post-procedure
Title
Performance accuracy
Description
LAP accuracy validation, concordance of the V-LAP implant measurement with pulmonary capillary wedge pressure (PCWP) measurement
Time Frame
At index (Implantation visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction. 2. 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. 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. 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 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dedi Erdheim
Phone
+972 72 342 5462
Email
dedi@vectoriousmedtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Bayés-Genís, MD PhD
Organizational Affiliation
Universitari Germans Trias i Pujol in Badalona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Meerkin, MD
Organizational Affiliation
Shaare Zedek Medical Center Jerusalem, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ran Kornowski, MD PhD
Organizational Affiliation
Rabin Belinson, Medical Center - Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filippo Crea, MD PhD
Organizational Affiliation
Universitario Agostino Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Belinson, Medical Center - Israel
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Kornowski, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance Chronic Heart Failure

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