New bendable tube could make heart valve surgery safer
NCT ID NCT07320274
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new device called the ArcFlex Sheath, a bendable tube used during TAVR surgery to replace a faulty aortic valve. The goal is to see if it helps doctors position the new valve more easily and safely compared to a standard sheath. About 180 people who need TAVR surgery will take part. The study will measure how often the surgery is successful and track survival rates at 30 days and one year.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- ArcFlex Sheath (a bendable tube used during heart valve replacement surgery)
- What this could lead to
- If it works, this could make TAVR heart valve surgery safer and more successful by helping doctors position the new valve more easily.
- What could go wrong
- This is an early-stage device trial with only 180 people, so results may not apply to everyone. There are always risks with any new surgical tool, such as damage to blood vessels.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.