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

> **NCT06816485** · NA · RECRUITING · sponsor: **Biosensors Europe SA** · enrollment: 93 (estimated)

## Conditions studied

- Aortic Diseases

## Interventions

- **DEVICE:** PTV (Percutaneous Transcatheter Valvuloplasty) Balloon

## Key facts

- **NCT ID:** NCT06816485
- **Lead sponsor:** Biosensors Europe SA
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-12-15
- **Primary completion:** 2026-08
- **Final completion:** 2026-08
- **Target enrollment:** 93 (ESTIMATED)
- **Last updated:** 2026-04-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06816485

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06816485, "INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT06816485. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*