Actively Recruiting
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Led by Biosensors Europe SA · Updated on 2026-04-16
93
Participants Needed
9
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic severe calcific stenosis of native aortic valve with an aortic valve area (AVA) 641.0 cm2 or an AVA index 640.6 cm2/m2 and mean aortic pressure gradient 6540mmHg or maximal transaortic velocity 654.0m/s or Doppler velocity index 640.25 on echocardiography
- Agreement by local multi-disciplinary Heart Team on indication and eligibility for TAVI
- Age 18 years or older
- Signed Patient Informed Consent Form
- Willing and able to comply with study requirements
- Planned for trans-femoral procedure
You will not qualify if you...
- Mean aortic annulus diameter less than 16 mm or greater than 30 mm measured by CT or bioprosthesis internal diameter
- Echocardiographic evidence of intracardiac thrombus, mass, or vegetation
- Significant aortic disease preventing safe advancement of TAVI system
- Severe ilio-femoral vessel disease preventing safe TAVI procedure
- Severe tricuspid regurgitation and/or failing right heart
- Severe left ventricular dysfunction with ejection fraction less than 20%
- Active endocarditis or other acute infections
- Renal failure requiring continuous renal replacement therapy
- Untreated clinically significant coronary artery disease requiring revascularization
- Acute myocardial infarction within 30 days before procedure
- Symptomatic carotid or vertebral artery disease requiring intervention or recent intervention within 45 days
- Stroke or transient ischemic attack within 6 months or prior stroke with moderate or severe disability
- History of bleeding disorders or acute blood abnormalities (low platelets, anemia, leukopenia)
- Severe mitral valve insufficiency (greater than 3+)
- Known allergy to contrast media or contraindications to anticoagulant, anti-platelet medication, nitinol alloy, or bovine tissue
- Participation in another investigational drug or device study
- Pregnancy or intention to become pregnant during study
- Unicuspid aortic valve
- Non-calcified aortic stenosis
- High risk of coronary occlusion due to specific heart anatomy
- Isolated aortic insufficiency
- Presence of a permanent pacemaker
- Pre-existing left bundle branch block, right bundle branch block, or grade 2 or 3 AV block
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
2
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
3
Hospital Universitario Reina Sofia
Córdoba, Spain
Actively Recruiting
4
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005
Actively Recruiting
5
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
6
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
7
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
8
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
9
Hospital Clínico Universitario de Valladolid (HCUV)
Valladolid, Spain, 47003
Actively Recruiting
Research Team
A
Anders Jönsson
CONTACT
D
Diana Schuette
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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