Recruiting

Testing a new device to repair a leaky heart valve

Plain-English translation of NCT07172477 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated June 2026 · How we translate trials

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 early-stage trial is testing a new device called Pivot Extend designed to repair a leaky tricuspid valve in your heart. Instead of open-heart surgery, doctors will implant this device using a catheter—a thin tube inserted through your blood vessels. The trial will evaluate whether the treatment is safe and whether it improves your symptoms.

Severe tricuspid regurgitation (when the valve leaks significantly) typically requires heart surgery, which carries high risks and may not be possible for elderly patients or those with other serious health conditions. This trial exists to see if the Pivot Extend device offers a safer alternative for patients who cannot safely undergo traditional surgery.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have severe tricuspid regurgitation (a leaky heart valve) causing symptoms such as shortness of breath or fatigue
your symptoms persist even after taking heart medications for at least 30 days
your heart team (cardiologist and cardiac surgeon) has determined you are suitable for a catheter-based valve procedure rather than open surgery
you are able to follow study instructions and commit to the full duration of the trial

You likely don't qualify if…

you have blood clots, emboli, or masses in your heart or lungs
you have bleeding disorders or cannot take blood-thinning medications
you have had major bleeding in the past or are at high risk for gastrointestinal bleeding
you have had a stroke or mini-stroke within the past month, or a heart attack within the past month
you have severe anemia, very low platelet counts, or other conditions that significantly limit life expectancy

What participation looks like

If you are accepted into the trial, you will undergo screening tests including heart imaging and blood work to confirm you are a good candidate. The Pivot Extend device will then be implanted in a catheter-based procedure (less invasive than open surgery). After implantation, you will have follow-up visits to monitor your recovery, check how well the device is working, and assess whether your heart symptoms have improved.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(1 site)

Australia

Macquarie University, Macquarie Park, New South Wales