Recruiting

Testing a wireless heart pressure monitor implant for advanced heart failure

Plain-English translation of NCT05448833 on ClinicalTrials.gov ↗ · Source last updated May 2025 · Translation generated June 2026 · How we translate trials

Read our Heart Failure research guide →

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study is testing the V-LAP System, a wireless implant that measures pressure inside the heart and sends data to your doctor. The device is placed through a minimally invasive procedure, allowing you to monitor your heart health from home using a smartphone app. The goal is to help your doctor adjust your heart failure medications more precisely, reducing hospital visits and improving how you feel.

Advanced heart failure is a serious condition that often leads to repeated hospitalizations. This treatment aims to give doctors real-time information about your heart's pressure levels, so they can make medication adjustments before you get dangerously ill, rather than only reacting after you're hospitalized.

Do you qualify?

You likely qualify if…

you have been diagnosed with heart failure (either from a heart attack or other causes) for at least 6 months
you have heart failure symptoms classified as mild-to-moderate (NYHA Class II) or moderate (NYHA Class III)
you have been hospitalized or visited an emergency room for heart failure congestion in the past 12 months and received IV diuretics
you have elevated blood markers (BNP or NT-proBNP) that indicate heart failure stress
you are already taking the maximum tolerated doses of standard heart failure medications, with doses stable for at least 1 month

You likely don't qualify if…

you have not been on heart failure medications for at least 3 months before enrollment
you have had a cardiac resynchronization therapy (CRT) device implanted less than 30 days before your most recent heart failure hospitalization
you are not able to use a smartphone app or comply with daily home monitoring
you have certain heart rhythm problems or structural heart conditions that make the implant procedure unsafe
you are pregnant or planning to become pregnant

What participation looks like

You will undergo a minimally invasive procedure to have the V-LAP implant placed through your groin vein into your heart wall. After recovery, you'll measure your heart pressure daily at home using the device and a smartphone app, which will guide you on whether to adjust your medications (as prescribed by your doctor) or contact your study team. Your doctor will monitor your data remotely and adjust your heart failure treatment plan as needed, with regular study visits to track your progress.

AI-generated summary from trial data · Jun 22, 2026 · Not medical advice

Trial locations(1 site)

Israel

Rabin Belinson, Medical Center - Israel, Petah Tikva