Actively Recruiting
A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
Led by Vectorious Medical Technologies Ltd. · Updated on 2025-05-30
10
Participants Needed
1
Research Sites
198 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
A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 22 to 88 years
- Diagnosis of ischemic or non-ischemic cardiomyopathy with heart failure for at least 6 months
- NYHA Class II heart failure with at least one hospitalization or equivalent event in the past 12 months or NYHA Class III heart failure
- Elevated Brain Natriuretic Peptide (BNP) or N-terminal pro-BNP (NT-proBNP) levels within 90 days of baseline visit
- Receiving maximally tolerated guideline-directed medical therapy for heart failure, stable doses for at least 1 month
- Cardiac rhythm management device therapy implanted at least 3 months prior if indicated or documented clinical contraindication or refusal
- Minimum technological knowledge and access to a smartphone or tablet with internet
- Provide informed consent and able to comply with study requirements
You will not qualify if you...
- Age under 22 years
- NYHA Class IV heart failure and ACC/AHA Stage D
- Major cardiovascular or neurovascular event within 6 months prior to baseline
- Resting systolic blood pressure below 90 or above 180 mmHg at baseline
- Left ventricular end-diastolic diameter greater than 8 cm
- Atrial septal defect or patent foramen ovale with more than trace shunting or prior septal correction with certain heart abnormalities
- Untreated severe valve lesions or other specific heart diseases causing heart failure
- Uncontrolled heart rate abnormalities (tachyarrhythmia or bradycardia below 45 bpm)
- Intractable heart failure with resting symptoms despite maximal therapy or use of ventricular assist device
- Intolerance to key heart failure medications for reduced ejection fraction patients
- Recent acute coronary syndrome, cardiac surgery, or related procedures within 90 days
- Ineligibility for emergency cardiac surgery
- Pregnancy or planning pregnancy
- Life expectancy under 12 months or pending heart transplant
- Coagulopathy or contraindications to anticoagulant/antiplatelet therapy
- Severe allergy to contrast dye
- Severe kidney or liver impairment
- Recent gastrointestinal bleeding
- Severe chronic pulmonary disease requiring continuous oxygen or steroids
- Active infection requiring antibiotics or elevated white blood cell count
- History of drug addiction, alcohol abuse, or recent psychiatric hospitalization
- Current participation in another clinical study
- Contraindications for trans-septal puncture or related procedures
- Anatomical or vascular issues preventing device implantation
- Severe pulmonary hypertension not responsive to treatment
- Uncorrected abnormal blood pressure at procedure time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
One Boston Medical Center Place
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
D
Dedi Erdheim, Mr.
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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