RecruitingNot ApplicableNCT05712824

V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF

A Multi-center, Open-label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System


Sponsor

Vectorious Medical Technologies Ltd.

Enrollment

10 participants

Start Date

Dec 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 22 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small wireless implantable sensor called the V-Lap system that monitors pressure in the left side of the heart in patients with advanced heart failure, to see if it can help doctors make better treatment decisions. **You may be eligible if...** - You have heart failure (either ischemic or non-ischemic) that has been diagnosed for at least 6 months - You have moderate-to-severe heart failure symptoms (NYHA class II or III) - You have been hospitalized or had an urgent clinic visit for heart failure in the past 12 months related to fluid buildup - Your BNP or NT-proBNP (heart failure blood markers) are above a certain level - You are on the best available medication for heart failure **You may NOT be eligible if...** - You are already on a left ventricular assist device or awaiting urgent heart transplant - You have had a recent major cardiac surgery or procedure - You have structural heart features incompatible with device placement (e.g., mechanical mitral valve, very small atrial opening) - You have a serious kidney condition (dialysis) or liver failure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEV-LAP™ SYSTEM

Delivery of the V-LAP™ implant by right heart catheterization. A catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.


Locations(3)

Aleksandre Aladashvili Clinic

Tbilisi, Georgia, Georgia

Jerarsi Clinic

Tbilisi, Georgia, Georgia

Tbilisi Medical Institute- TIM

Tbilisi, Georgia, Georgia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05712824


Related Trials