Actively Recruiting
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance Chronic Heart Failure
Led by Vectorious Medical Technologies Ltd. · Updated on 2025-05-30
25
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 22 to 88 years
- Have ischemic or non-ischemic cardiomyopathy with heart failure diagnosed for at least 6 months
- NYHA Class II or III heart failure at Baseline Visit regardless of ejection fraction
- At least one heart failure hospitalization or equivalent visit in the last 12 months requiring intravenous diuretic treatment
- Elevated outpatient BNP or NT-proBNP levels within 90 days before Baseline Visit
- Receiving maximally tolerated guideline-directed medical therapy for heart failure for at least 3 months prior to Baseline Visit
- Stable medication doses for at least 1 month prior to Baseline Visit, except diuretics
- If indicated, have cardiac rhythm management device therapy implanted at least 3 months prior to Baseline Visit or documented contraindication/refusal
- Provide informed consent and able to comply with study procedures
You will not qualify if you...
- Age under 22 or over 88 years
- NYHA Class IV and ACC/AHA Stage D heart failure
- Major cardiovascular or neurovascular event within 6 months before Baseline Visit
- Resting systolic blood pressure below 90 or above 180 mmHg
- Left ventricular end-diastolic diameter greater than 8 cm
- Presence of atrial septal defect or patent foramen ovale with significant shunting or previous correction with device and abnormal septal anatomy
- Untreated severe valve lesions or other specified cardiac conditions causing heart failure
- Uncontrolled heart rate abnormalities (heart rate under 45 bpm)
- Intractable heart failure with resting symptoms despite maximal therapy including certain medications or devices
- Intolerance to key heart failure medications for patients with reduced ejection fraction
- Recent acute coronary syndrome, cardiac surgery, or related procedures within 90 days
- Not eligible for emergency cardiac or vascular surgery
- Women of childbearing potential
- Life expectancy less than 12 months or listed for cardiac transplant within 12 months
- Coagulopathy or contraindication to anticoagulation or antiplatelet therapy
- Life-threatening allergy to contrast dye not manageable by pre-medication
- Severe kidney or liver impairment
- Recent gastrointestinal bleeding
- Severe chronic pulmonary disease requiring oxygen or steroids
- Active infection requiring antibiotics or elevated white blood count
- History of active drug addiction, alcohol abuse, or psychiatric hospitalization within 2 years
- Currently participating in another clinical study
- Contraindications for trans-septal puncture or specific imaging procedures
- Anatomical abnormalities preventing device implantation
- Inadequate vascular access or intolerance to right heart catheterization
- Severe pulmonary hypertension not responsive to vasodilators
- Resting systolic blood pressure not correctable with treatment during procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rabin Belinson, Medical Center - Israel
Petah Tikva, Israel
Actively Recruiting
Research Team
D
Dedi Erdheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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