An interventional study of PTV (Percutaneous Transcatheter Valvuloplasty) Balloon in Aortic Diseases, sponsored by Biosensors Europe SA. Recruiting at 9 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Biosensors Europe SA (part of Blue Sail Medical Co., Ltd.) · Not applicable, Interventional, and Treatment
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:
108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
This study's planned enrollment of 93 is close to the median of 90 across 42 interventional studies indexed under Aortic Diseases.
Browse Aortic Diseases studies →Biosensors Europe SA is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
First submitted after Biosensors Europe SA became part of Blue Sail Medical Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients suffering from a severe aortic stenosis and scheduled for a TAVI.
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.
The primary endpoint is the rate of new conduction system abnormalities, including 3rd AV block, LBBB, or RBBB, occurring after pre-dilatation using the study device
The primary endpoint evaluates the incidence of new conduction system abnormalities that emerge after pre-dilatation using a PTV Balloon, the study device. These conduction system abnormalities include: * Third-degree atrioventricular (AV) block: A complete disruption of electrical signals between the atria and ventricles, requiring pacemaker placement in most cases. * Left bundle branch block (LBBB): A condition where electrical impulses are delayed or blocked in the left bundle branch, potentially leading to desynchrony in ventricular contraction. * Right bundle branch block (RBBB): A delay or blockage of electrical signals in the right bundle branch, which can affect the heart's pumping efficiency.
Time frame: During TAVI procedure
Successful inflation and deflation of the study device during pre-dilatation
Rate of study devices successfully inflated and deflated
Time frame: Measured during TAVI procedure
Balloon rupture during pre-dilatation
absolute number and percentages of balloon ruptures during pre-dilatation
Time frame: measured during TAVI procedure
Number of pre-dilatations performed
Total number
Time frame: Measured during TAVI procedure
Need for post-dilatation and reason (under expansion, PVL, other)
absolute number and percentages of post-dilatation and reason why
Time frame: measured during TAVI procedure
Successful inflation and deflation of the balloon during post-dilatation
Rate of study devices successfully inflated and deflated
Time frame: measured during TAVI procedure
Number of post-dilatations performed
absolute number and percentages of post-dilatation
Time frame: measured during TAVI procedure
Balloon rupture during post-dilatation
absolute number and percentages of balloon ruptures during post-dilatation
Time frame: measured during TAVI procedure
Rate of conduction system abnormalities induced by post-dilatation
Evaluates the incidence of new conduction system abnormalities that emerge after post-dilatation using a PTV Balloon, the study device. These conduction system abnormalities include: * Third-degree atrioventricular (AV) block: A complete disruption of electrical signals between the atria and ventricles, requiring pacemaker placement in most cases. * Left bundle branch block (LBBB): A condition where electrical impulses are delayed or blocked in the left bundle branch, potentially leading to desynchrony in ventricular contraction. * Right bundle branch block (RBBB): A delay or blockage of electrical signals in the right bundle branch, which can affect the heart's pumping efficiency.
Time frame: measured during TAVI procedure
Degree of aortic regurgitation (para-valvular) post-dilatation
absolute number and percentages of mild, moderate or severe aortic regurgitation
Time frame: measured during TAVI procedure
New onset conduction disorders and arrhythmias at any other times during the procedure
absolute number and percentages of new onset conduction disorders and arrhythmias
Time frame: measured during TAVI procedure
Annular rupture
absolute number and percentages of annular ruptures
Time frame: measured during TAVI procedure
Usability assessment of the device per case
Absolute number and percentages within each category of the below scale: Unsuccessful Poor Average Good Excellent
Time frame: After TAVI procedure
All-cause mortality
absolute number and percentages of deaths
Time frame: From enrollment until the patient is discharged (max. 7 days)
Cardiovascular mortality
absolute number and percentages of cardiovascular deaths
Time frame: From enrollment until the patient is discharged (max. 7 days)
Neurological events (All stroke, stroke disability, transient ischemic attack)
absolute number and percentages of neurological events
Time frame: From enrollment until the patient is discharged (max. 7 days)
Procedure or valve related hospitalization
absolute number and percentages of hospitalizations
Time frame: From TAVI procedure until the patient is discharged (max. 7 days)
Bleeding
absolute number and percentages of bleeding events
Time frame: From enrollment until the patient is discharged (max. 7 days)
Major vascular complications
absolute number and percentages of major vascular complications
Time frame: From enrollment until the patient is discharged (max. 7 days)
Major cardiac structural complications
absolute number and percentages of major cardiac structural complications
Time frame: From enrollment until the patient is discharged (max. 7 days)
Conversion to open surgery
absolute number and percentages of conversions to open surgery
Time frame: measured during TAVI procedure
Valve malposition (valve migration, valve embolization, ectopic valve deployment)
Absolute number and percentages of valve malpositions
Time frame: measured during TAVI procedure
Started Dec 2025 (actual). Primary completion is estimated for Aug 2026, 8 months after the start.
Of 21 interventional studies with no phase under Aortic Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 107. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
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