Aortic DiseasesNCT06816485
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
A study testing PTV (Percutaneous Transcatheter Valvuloplasty) Balloon in people with Aortic Diseases, run by Biosensors Europe SA at 9 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases
- What is being tested?
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 9 sitesSpain
- Study dates
- 15 Dec 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography
- Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI
- Age ≥18 years
- Patient has signed the Patient Informed Consent Form
- Patient is willing and able to comply with requirements of the study
- Patients planned for trans-femoral procedure
Who cannot join
- Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16 mm or >30 mm
- Echocardiographic evidence of intracardiac thrombus, mass or vegetation (site-reported)
- Significant disease of the aorta that would preclude safe advancement of the TAVI system
- Severe ilio-femoral vessel disease that would preclude safe performance of the TAVI procedure
- Severe tricuspid regurgitation and/or failing right heart (site-reported)
- Severe left ventricular dysfunction with ejection fraction (EF) <20% (site-reported)
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- Evidence of active endocarditis or other acute infections
- Renal failure requiring continuous renal replacement therapy
- Untreated clinically significant coronary artery disease requiring revascularization
- Acute MI ≤30 days prior to the index procedure
- Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score >2)
- History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets <80,000/µl), acute anemia (hemoglobin <10 g/dl), leukopenia (WBC <3000/ µl)
- Severe (greater than 3+) mitral insufficiency (site-reported)
- Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
- Currently participating in another investigational drug or device study
- Pregnancy or intend to become pregnant during study participation
- Unicuspid aortic valve
- Non-calcified aortic stenosis
- Identified high risk of coronary occlusion due to Sinus of Valsalva anatomy and/or bulky calcified aortic valve leaflets in close proximity to coronary ostia
- Isolated Aortic Insufficiency
- Patients with a permanent pacemaker
- Patients with pre-existing LBBB, RBBB and AV block 2 and 3
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Lluis Asmarats Serra, +34628839525, lasmarats@santpau.cat
- Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
Rafael Romaguera, +34677592544, rromaguera@bellvitgehospital.cat
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
Soledad Ojeda Pineda, +34696662533, soledad.ojeda18@gmail.com
- Recruiting
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Antonio Gomez Menchero, ´+34639217965, aegmenchero@gmail.com
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
Luisa Salido Tahoces, +34913368415, luisasalido@gmail.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Fernando Sarnago, Dr, +34637854412, fernando.sarnago@salud.madrid.org
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
José Díaz Francisco Fernández, Dr, +34 616676095, jfdiazf@yahoo.es
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Jorge Sanz Sanchez, +34660360598, sjorge4@gmx.com
- Recruiting
Hospital Clínico Universitario de Valladolid (HCUV)
Valladolid, 47003
Ignacio Amat Santos, +34983420000, ijamat@gmail.com
About this study
Official title: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
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:
- Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation.
- Will be followed up until discharge or up to 7 days, whichever happens first.
- Conditions
- Aortic Diseases
- Being tested
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Keywords
- PTV Balloon, TAVI, Aortic Valve Stenosis, Balloon Aortic Valvuloplasty
- Medical subject headings
- Aortic Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTV (Percutaneous Transcatheter Valvuloplasty) BalloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Biosensors PTV balloon catheter | Experimental | Patients suffering from a severe aortic stenosis and scheduled for a TAVI. Receives: Device: PTV (Percutaneous Transcatheter Valvuloplasty) Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During TAVI procedure
Secondary outcomes (21)
Successful inflation and deflation of the study device during pre-dilatation
Rate of study devices successfully inflated and deflated
Measured: Measured during TAVI procedure
Balloon rupture during pre-dilatation
absolute number and percentages of balloon ruptures during pre-dilatation
Measured: measured during TAVI procedure
Number of pre-dilatations performed
Total number
Measured: Measured during TAVI procedure
Need for post-dilatation and reason (under expansion, PVL, other)
absolute number and percentages of post-dilatation and reason why
Measured: measured during TAVI procedure
Successful inflation and deflation of the balloon during post-dilatation
Rate of study devices successfully inflated and deflated
Measured: measured during TAVI procedure
Number of post-dilatations performed
absolute number and percentages of post-dilatation
Measured: measured during TAVI procedure
Balloon rupture during post-dilatation
absolute number and percentages of balloon ruptures during post-dilatation
Measured: 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.
Measured: measured during TAVI procedure
Degree of aortic regurgitation (para-valvular) post-dilatation
absolute number and percentages of mild, moderate or severe aortic regurgitation
Measured: 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
Measured: measured during TAVI procedure
Annular rupture
absolute number and percentages of annular ruptures
Measured: 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
Measured: After TAVI procedure
All-cause mortality
absolute number and percentages of deaths
Measured: From enrollment until the patient is discharged (max. 7 days)
Cardiovascular mortality
absolute number and percentages of cardiovascular deaths
Measured: 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
Measured: From enrollment until the patient is discharged (max. 7 days)
Procedure or valve related hospitalization
absolute number and percentages of hospitalizations
Measured: From TAVI procedure until the patient is discharged (max. 7 days)
Bleeding
absolute number and percentages of bleeding events
Measured: From enrollment until the patient is discharged (max. 7 days)
Major vascular complications
absolute number and percentages of major vascular complications
Measured: From enrollment until the patient is discharged (max. 7 days)
Major cardiac structural complications
absolute number and percentages of major cardiac structural complications
Measured: From enrollment until the patient is discharged (max. 7 days)
Conversion to open surgery
absolute number and percentages of conversions to open surgery
Measured: measured during TAVI procedure
Valve malposition (valve migration, valve embolization, ectopic valve deployment)
Absolute number and percentages of valve malpositions
Measured: measured during TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start15 Dec 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, prospective, multi-center, trial designed to enroll approximately 78 patients. All patients will undergo pre-dilatation using at least one study device. Some patients may also undergo post-dilatation with the study device as clinically indicated. All patients will be followed until discharge (maximum 7 days) for data collection. Patients will be enrolled in up to 10 investigational centers in Spain. The sample size is based on the expected event rate for patients to be treated with a self-expanding valves only. In addition, the study will enroll, in a separate cohort, 15 patients that will be treated with balloon-expanding valves. This cohort will be analyzed and treated separately.
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816485
- Sponsor's protocol ID
- 24-EU-01
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06816485
- Acronym / sponsor ID
- 24-EU-01
- Conditions
- Aortic Diseases
- Keywords
- PTV Balloon, TAVI, Aortic Valve Stenosis, Balloon Aortic Valvuloplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation.
- Will be followed up until discharge or up to 7 days, whichever happens first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective, multi-center, trial designed to enroll approximately 78 patients. All patients will undergo pre-dilatation using at least one study device. Some patients may also undergo post-dilatation with the study device as clinically indicated. All patients will be followed until discharge (maximum 7 days) for data collection. Patients will be enrolled in up to 10 investigational centers in Spain. The sample size is based on the expected event rate for patients to be treated with a self-expanding valves only. In addition, the study will enroll, in a separate cohort, 15 patients that will be treated with balloon-expanding valves. This cohort will be analyzed and treated separately.
| Arm | Type | Receives |
|---|---|---|
| Biosensors PTV balloon catheter | Experimental | Device: PTV (Percutaneous Transcatheter Valvuloplasty) BalloonPatients suffering from a severe aortic stenosis and scheduled for a TAVI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography
- Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI
- Age ≥18 years
- Patient has signed the Patient Informed Consent Form
- Patient is willing and able to comply with requirements of the study
Key exclusion criteria (23 listed)
- Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16 mm or >30 mm
- Echocardiographic evidence of intracardiac thrombus, mass or vegetation (site-reported)
- Significant disease of the aorta that would preclude safe advancement of the TAVI system
- Severe ilio-femoral vessel disease that would preclude safe performance of the TAVI procedure
- Severe tricuspid regurgitation and/or failing right heart (site-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTV (Percutaneous Transcatheter Valvuloplasty) BalloonMinimally 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. | Device | Biosensors PTV balloon catheter |
Primary outcome
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
Time frame: During TAVI procedure
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.
21 secondary outcomes
Successful inflation and deflation of the study device during pre-dilatation
Time frame: Measured during TAVI procedure
Balloon rupture during pre-dilatation
Time frame: measured during TAVI procedure
Number of pre-dilatations performed
Time frame: Measured during TAVI procedure
Need for post-dilatation and reason (under expansion, PVL, other)
Time frame: measured during TAVI procedure
Successful inflation and deflation of the balloon during post-dilatation
Time frame: measured during TAVI procedure
Number of post-dilatations performed
Time frame: measured during TAVI procedure
Balloon rupture during post-dilatation
Time frame: measured during TAVI procedure
Rate of conduction system abnormalities induced by post-dilatation
Time frame: measured during TAVI procedure
Degree of aortic regurgitation (para-valvular) post-dilatation
Time frame: measured during TAVI procedure
New onset conduction disorders and arrhythmias at any other times during the procedure
Time frame: measured during TAVI procedure
Annular rupture
Time frame: measured during TAVI procedure
Usability assessment of the device per case
Time frame: After TAVI procedure
All-cause mortality
Time frame: From enrollment until the patient is discharged (max. 7 days)
Cardiovascular mortality
Time frame: From enrollment until the patient is discharged (max. 7 days)
Neurological events (All stroke, stroke disability, transient ischemic attack)
Time frame: From enrollment until the patient is discharged (max. 7 days)
Procedure or valve related hospitalization
Time frame: From TAVI procedure until the patient is discharged (max. 7 days)
Bleeding
Time frame: From enrollment until the patient is discharged (max. 7 days)
Major vascular complications
Time frame: From enrollment until the patient is discharged (max. 7 days)
Major cardiac structural complications
Time frame: From enrollment until the patient is discharged (max. 7 days)
Conversion to open surgery
Time frame: measured during TAVI procedure
Valve malposition (valve migration, valve embolization, ectopic valve deployment)
Time frame: measured during TAVI procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTV (Percutaneous Transcatheter Valvuloplasty) Balloon in people with Aortic Diseases, run by Biosensors Europe SA at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Jönsson (0041218048000, a.jonsson@biosensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During TAVI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.