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A Multi-center, National, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP12 System for Wirelessly Measuring and Monitoring Left Atrial Pressure in Patients With Advanced Chronic Heart Failure
Led by Vectorious Medical Technologies Ltd. · Updated on 2025-05-30
10
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the V-LAP12 System in people with heart failure classified as New York Heart Association (NYHA) functional class II and III, regardless of their left ventricular ejection fraction. This study aims to monitor left atrial pressure (LAP) wirelessly in patients with chronic symptomatic ACC/AHA Stage C heart failure. The goal is to reduce hospitalizations and improve quality of life by using pressure-guided medical management through a physician-directed patient self-management approach. Participants will receive the V-LAP12 implant through a catheter-based procedure involving a trans-septal puncture to place the device within the inter-atrial septum. After implantation, patients will measure their LAP daily at home and be trained to use a smartphone application called V-LAP-PSM, which guides them on self-adjusting treatment based on physician instructions and advises when to contact healthcare providers. The study includes follow-up periods to assess safety and device usability. During the study, participants will undergo regular assessments including LAP measurements for up to 12 months, and monitoring for major adverse cardiac and neurological events (MACNE) for six months after the procedure. Additional evaluations up to 24 months include questionnaires on usability, quality of life, heart failure symptoms, and hospitalization rates and durations. Participants must comply with required tests, treatment instructions, and follow-up visits over the study duration, which begins with implantation and continues with ongoing monitoring and self-management support.
CONDITIONS
Brief 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
- Diagnosed with ischemic or non-ischemic cardiomyopathy and heart failure for at least 6 months
- NYHA Class II or III heart failure documented at baseline
- At least one heart failure hospitalization or equivalent within the last 12 months with intravenous diuretic treatment
- Elevated Brain Natriuretic Peptide (BNP) or N-terminal pro-BNP levels within 90 days before baseline
- Receiving guideline-directed medical therapy for heart failure per ACC/AHA or ESC guidelines
- Have access to and ability to use a smartphone or tablet with internet for self-management app
- Provide informed consent and willing to comply with study procedures
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 last 6 months
- Resting systolic blood pressure less than 90 or greater than 180 mmHg
- Left ventricular end-diastolic diameter greater than 8 cm
- Atrial septal defect, patent foramen ovale with significant shunting, or certain congenital heart defects
- Untreated severe valve lesions or other specified heart conditions causing heart failure
- Uncontrolled abnormal heart rhythms
- Intractable heart failure with resting symptoms despite maximal therapy
- Intolerance to key heart failure medications
- Acute coronary syndrome or major cardiac surgery within 90 days
- Pregnancy or planning pregnancy
- Life expectancy less than 12 months or listed for cardiac transplant
- Coagulopathy or contraindications to anticoagulant therapy
- Severe kidney or liver impairment
- Recent gastrointestinal bleeding
- Severe chronic pulmonary disease requiring oxygen or steroids
- Active infection requiring antibiotics
- History of drug addiction, alcohol abuse, or recent psychiatric hospitalization
- Current participation in another clinical study
- Contraindications to trans-septal puncture or certain heart imaging procedures
- Anatomical or vascular issues preventing device implantation
- Severe pulmonary hypertension not responsive to treatment
- Resting blood pressure outside safe ranges not corrected by treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and immediate recovery period
Participants undergo percutaneous implantation of the V-LAP™ device by right heart catheterization, including a trans-septal puncture procedure to place the implant within the inter-atrial septum.
1 procedure visit and immediate post-procedure monitoring
Duration - Up to 12 months post-procedure
Participants measure and monitor left atrial pressure daily at home using the V-LAP™ System and are trained on the use of the device for self-management with physician guidance through a smartphone application.
Regular follow-up visits as scheduled by the study team
Duration - Up to 24 months post-procedure
Participants continue safety and usability assessments, including monitoring for major adverse cardiac and neurological events and quality of life evaluations with questionnaires.
Periodic visits for assessments and questionnaires
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.
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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