INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
StatusRecruiting
PhaseNot applicable
Started2025-12-15
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 16, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.
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.
Amendment record
Amended 2 times since 2025-02-06; most recent filed 2026-04-15. Every amendment is listed below.
Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.
2026-04-15
Amendment Study Status, Contacts/Locations v2
2025-12-22
Amendment Not Yet Recruiting→Recruiting Study Status, Oversight, Study Design, Contacts/Locations v1
2025-02-06
Original filing
| NCT Number |
NCT06816485 |
| Lead Sponsor |
Biosensors Europe SA
|
| Conditions |
Aortic Diseases |
| Enrollment |
93 participants |
| Start Date |
2025-12-15 |
| Primary Completion |
2026-08 (estimated) |
| Study Completion |
2026-08 (estimated) |
| Updated on ClinicalTrials.gov |
2026-04-16 |