Key result
The V-LAP left atrium monitoring system was safely implanted in 24 patients with heart failure, yielding no device-related complications and accurately reporting left atrial pressure at 3 months.
Why the study?
Patients with heart failure are at increased risk of hospital admissions, prompting evaluation of the feasibility, safety, and accuracy of a novel wireless left atrial pressure monitoring system.
Does the V-LAP system safely and accurately monitor left atrial pressure in patients with NYHA class III heart failure?
Does the V-LAP system safely and accurately monitor left atrial pressure in patients with NYHA class III heart failure?
The V-LAP wireless left atrial pressure monitoring system appears safe, feasible, and accurate for remote monitoring in patients with NYHA class III heart failure.
Supports feasibility and safety of wireless LAP monitoring in HF; leaves open outcome benefits in larger trials.
OBJECTIVE: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF. METHODS: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes. RESULTS: To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076). CONCLUSION: The V-LAP left atrium monitoring system appears to be safe and accurate.
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Perl et al. (2022) studied Heart failure (n=24). V-LAP left atrium monitoring system was evaluated on Successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes. The V-LAP left atrium monitoring system was safely implanted in 24 patients with heart failure, yielding no device-related complications and accurately reporting left atrial pressure at 3 months.
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