Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new medical device called the PTV Balloon, designed to open the heart valve area before and possibly after placing a new valve in patients with severe aortic stenosis undergoing a transcatheter aortic valve implantation (TAVI) procedure. The study aims to determine how often patients develop new heart conduction problems after using this device during pre-dilatation. This investigation is sponsored by Biosensors Europe SA and focuses on the safety and performance of the PTV Balloon in this setting. During the study, participants will receive the TAVI procedure where the PTV Balloon is used for pre-dilatation and may also be used for post-dilatation. The device's inflation, deflation, and any complications such as balloon rupture or valve malposition will be monitored closely during the procedure. The study includes one group of patients treated with the PTV Balloon catheter, and all treatments occur minimally invasively through the femoral artery. Participants will be followed from enrollment through the TAVI procedure until discharge or up to 7 days, whichever comes first. Researchers will assess heart conduction abnormalities, including specific heart blocks and arrhythmias, as well as other safety outcomes like mortality, neurological events, bleeding, and vascular complications. Usability of the device and procedure-related hospitalizations will also be recorded, ensuring comprehensive monitoring during this short-term follow-up period.
CONDITIONS
Brief 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 a native aortic valve with an aortic valve area (AVA) 641.0 cm2 or AVA index 640.6 cm2/m2 and mean aortic pressure gradient 6540 mmHg or maximal transaortic velocity 654.0 m/s or Doppler velocity index 640.25 confirmed by echocardiography
- Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI
- Age 18 years or older
- Patient has signed the informed consent form
- Patient is willing and able to comply with study requirements
- Patients planned for trans-femoral procedure
You will not qualify if you...
- Mean aortic annulus diameter less than 16 mm or greater than 30 mm as measured by pre-procedural CT or internal diameter of the bioprosthesis
- Echocardiographic evidence of intracardiac thrombus, mass, or vegetation
- Significant aortic disease preventing safe advancement of the TAVI system
- Severe ilio-femoral vessel disease preventing safe TAVI procedure
- Severe tricuspid regurgitation or failing right heart
- Severe left ventricular dysfunction with ejection fraction below 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 prior to procedure
- Symptomatic carotid or vertebral artery disease requiring intervention or intervention within past 45 days
- Cerebrovascular accident or transient ischemic attack within 6 months or prior stroke with moderate or severe disability
- History of bleeding disorders or acute blood abnormalities including low platelets, anemia, or low white blood cells
- Severe mitral insufficiency greater than grade 3+
- Known hypersensitivity to contrast media or contraindication to anticoagulant or anti-platelet medications, nitinol alloy, or bovine tissue
- Currently participating in another investigational drug or device study
- Pregnancy or intent to become pregnant during study
- Unicuspid aortic valve
- Non-calcified aortic stenosis
- High risk of coronary occlusion due to anatomy or bulky calcified valve leaflets
- Isolated aortic insufficiency
- Presence of a permanent pacemaker
- Pre-existing left bundle branch block, right bundle branch block, or advanced atrioventricular block (2nd or 3rd degree)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of procedure
Participants undergo a minimally invasive procedure using the PTV balloon as part of the TAVI procedure to treat severe aortic stenosis.
1 procedure visit (in-person)
Duration - Up to 7 days after procedure
Participants are monitored for safety, device performance, and clinical outcomes until discharge.
Daily visits or assessments until discharge (maximum 7 days)
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
D
Diana Schuette
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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