New balloon aims to reduce heart rhythm problems during valve replacement

NCT ID NCT06816485

Recruiting now Disease control Sponsor: Biosensors Europe SA Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new balloon device used during a minimally invasive heart valve replacement procedure (TAVI) for people with severe aortic stenosis. The main goal is to see if the balloon causes fewer heart rhythm problems, like blockages that might need a pacemaker. About 93 participants will be followed for up to 7 days after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: PTV Balloon (a balloon device used to open the heart valve before and after placing a new valve)
What this could lead to: If successful, this could lead to a safer way to perform TAVI, reducing the risk of heart rhythm problems that require a pacemaker.
What could go wrong: This is an early-stage, small study (93 people) with very short follow-up (7 days). The device may not reduce risks as hoped, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

aortic disorder aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC DISEASES

Contacts and locations

Locations

Hospital Clínico Universitario de Valladolid (HCUV)
RECRUITING

Valladolid, 47003, Spain
Hospital Universitari de Bellvitge
RECRUITING

Barcelona, 08907, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Juan Ramon Jimenez
RECRUITING

Huelva, 21005, Spain
Hospital Universitario Ramon y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Universitario Reina Sofia
RECRUITING

Córdoba, Spain
Hospital Universitario Virgen del Rocio
RECRUITING

Seville, 41013, Spain
Hospital Universitario y Politécnico La Fe
RECRUITING

Valencia, 46026, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, 08025, Spain

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