Actively Recruiting
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF
Led by Vectorious Medical Technologies Ltd. · Updated on 2025-05-30
10
Participants Needed
3
Research Sites
310 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 CHF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ischemic or non-ischemic cardiomyopathy with heart failure for at least 6 months
- NYHA Class II or III heart failure documented at baseline visit
- At least one heart failure hospitalization or equivalent visit requiring IV diuretic in the past 12 months (if CRT device implanted, hospitalization must be at least 30 days after implantation)
- Elevated outpatient BNP (≥300 pg/ml) or NT-proBNP (≥1,500 pg/ml) within 90 days before baseline visit, adjusted for BMI and ARNI use
- Receiving maximally-tolerated guideline-directed medical therapy for heart failure as per ACC/AHA or ESC guidelines
- Stable drug doses for at least 1 month prior to baseline visit (except diuretics)
- Cardiac rhythm management device therapy implanted at least 3 months before baseline visit if indicated
- 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 events within 6 months before baseline
- Resting systolic blood pressure below 90 or above 180 mmHg
- Left ventricular end-diastolic diameter over 8 cm
- Atrial septal defect or patent foramen ovale with significant shunting or prior atrial septal interventions
- Untreated severe valve lesions or significant cardiac conditions causing heart failure
- Uncontrolled abnormal heart rhythms (tachycardia or bradycardia below 45 bpm)
- Intractable heart failure with resting symptoms despite maximal therapy
- Intolerance to ACE inhibitors, ARBs, ARNIs, or beta-blockers for patients with reduced ejection fraction
- Recent acute coronary events, major surgeries, or cardiac device procedures within 90 days
- Ineligibility for emergency open-heart, thoracic, or vascular surgery
- Women of childbearing age
- Life expectancy under 12 months or listed/received cardiac transplant
- Coagulopathy or contraindications to antiplatelet/anticoagulant treatments
- Severe allergies to contrast dye
- Severe kidney or liver impairment
- Recent gastrointestinal bleeding
- Severe chronic lung disease requiring oxygen or steroids
- Active infection requiring antibiotics or elevated white blood count
- History of active drug addiction, alcohol abuse, or recent psychiatric hospitalization
- Current participation in another clinical study
- Contraindications for trans-septal puncture or related imaging procedures
- Anatomical or vascular access issues preventing implantation
- Severe pulmonary hypertension not responsive to vasodilators
- Resting systolic blood pressure not correctable with fluids or vasodilators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Aleksandre Aladashvili Clinic
Tbilisi, Georgia, Georgia
Actively Recruiting
2
Jerarsi Clinic
Tbilisi, Georgia, Georgia
Actively Recruiting
3
Tbilisi Medical Institute- TIM
Tbilisi, Georgia, Georgia
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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