New balloon aims to reduce heart rhythm problems during valve replacement
NCT ID NCT06816485
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.
Disclaimer
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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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
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Hospital Clínico Universitario de Valladolid (HCUV)
RECRUITINGValladolid, 47003, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitari de Bellvitge
RECRUITINGBarcelona, 08907, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario Juan Ramon Jimenez
RECRUITINGHuelva, 21005, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, 28034, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario Reina Sofia
RECRUITINGCórdoba, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario Virgen del Rocio
RECRUITINGSeville, 41013, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario y Politécnico La Fe
RECRUITINGValencia, 46026, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital de la Santa Creu i Sant Pau
RECRUITINGBarcelona, 08025, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••