A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
- Conditions
- Heart Failure
- Interventions
- Device: V-LAP™ SYSTEM
- Registration Number
- NCT06147336
- Lead Sponsor
- Vectorious Medical Technologies Ltd.
- 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 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 subjects Heart Failure.
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 their healthcare provider (HCP).
Freedom from study (Device and/or system) related Major Adverse Cardiac and Neurological Events (MACNE as defined in the protocol) up to six months post-procedure, as adjudicated by the independent Clinical Events Committee.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description V-LAP™ System V-LAP™ SYSTEM 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.
- Primary Outcome Measures
Name Time Method LAP measurement Up to 12 months post-procedure Freedom from 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) Up to six 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
- Secondary Outcome Measures
Name Time Method Patient Global Assessment (PGA) Overall Up to 24 months post-procedure Change in Patient Global Assessment (PGA) Overall score at 6, 12, and 24 months vs. baseline.
Performance Score -3 - +3 (-3=Poor, +3=Excellent)Health Care Provider Usability Questionnaire 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. Performance Score 1-5 (1=Poor, 5=Excellent)
Usability Assessment - Patient Usability Questionnaire Up to 24 months post-procedure Usability assessment of the V-LAP system will be measured by questionnaires that will be completed by the patients. Performance Score 1-5 (1=Poor, 5=Excellent)
Target LAP range Up to 24 months post-procedure Ratio (percentage) of follow-up time in the target Left Atrial pressure (LAP) range as defined by the physician.
New York Heart Association (NYHA) functional class Up to 24 months post-procedure Change in NYHA functional class ranking at 6, 12, and 24 months vs. baseline. Stages of Heart Failure scoring 1-4 (1=High, 4=Low)
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall score Up to 24 months post-procedure Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall score at 6, 12, and 24 months vs. baseline.
Scores 1-7 (1=Minimum, 7=Maximum)Heart failure hospitalization rate Up to 12months post-procedure Heart failure hospitalization rate at 6 and 12 months (rate is calculated as the number of hospitalizations over individual patient follow-up duration).
Heart failure hospitalization duration Up to 12months post-procedure Heart failure hospitalization duration at 6 and 12 months (duration is calculated as number of days hospitalized over individual patient follow-up duration).