NCT06816485

INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis

Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in patients requiring a new heart valve. The main question it aims to answer is: What percentage of patients develop new heart conduction problems after using the investigational PTV Balloon for pre-dilatation? Participants will: 1. Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation. 2. Will be followed up until discharge or up to 7 days, whichever happens first.

Conditions

• Aortic Diseases

Interventions

Type	Name	Description
DEVICE	PTV (Percutaneous Transcatheter Valvuloplasty) Balloon	Minimally invasive medical procedure used to replace a diseased aortic valve without the need for open-heart surgery. It is commonly used to treat severe aortic stenosis, a condition in which the aortic valve becomes narrowed and restricts blood flow from the heart to the rest of the body.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-02-10
• Last updated: 2026-04-16

Locations

9 sites across 1 country: Spain