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

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Diseases
• Intervention / Treatment: Device: PTV (Percutaneous Transcatheter Valvuloplasty) Balloon

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Jönsson; Phone Number: 0041218048000; Email: a.jonsson@biosensors.com
• Study Contact Backup: Name: Diana Schuette; Phone Number: 00447970942022; Email: d.schuette@biosensors.com

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Lluis Asmarats Serra; Phone Number: +34628839525; Email: lasmarats@santpau.cat
  • Barcelona, Spain, 08907
    • Recruiting
    • Hospital Universitari de Bellvitge
    • Contact: Rafael Romaguera; Phone Number: +34677592544; Email: rromaguera@bellvitgehospital.cat
  • Córdoba, Spain
    • Recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Soledad Ojeda Pineda; Phone Number: +34696662533; Email: soledad.ojeda18@gmail.com
  • Huelva, Spain, 21005
    • Recruiting
    • Hospital Universitario Juan Ramon Jimenez
    • Contact: Antonio Gomez Menchero; Phone Number: ´+34639217965; Email: aegmenchero@gmail.com
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
    • Contact: Luisa Salido Tahoces; Phone Number: +34913368415; Email: luisasalido@gmail.com
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Fernando Sarnago, Dr; Phone Number: +34637854412; Email: fernando.sarnago@salud.madrid.org
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Contact: José Díaz Francisco Fernández, Dr; Phone Number: +34 616676095; Email: jfdiazf@yahoo.es
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politecnico La Fe
    • Contact: Jorge Sanz Sanchez; Phone Number: +34660360598; Email: sjorge4@gmx.com
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario de Valladolid (HCUV)
    • Contact: Ignacio Amat Santos; Phone Number: +34983420000; Email: ijamat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI
3. Age ≥18 years
4. Patient has signed the Patient Informed Consent Form
5. Patient is willing and able to comply with requirements of the study
6. Patients planned for trans-femoral procedure

Exclusion Criteria:

1. Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16 mm or >30 mm
2. Echocardiographic evidence of intracardiac thrombus, mass or vegetation (site-reported)
3. Significant disease of the aorta that would preclude safe advancement of the TAVI system
4. Severe ilio-femoral vessel disease that would preclude safe performance of the TAVI procedure
5. Severe tricuspid regurgitation and/or failing right heart (site-reported)
6. Severe left ventricular dysfunction with ejection fraction (EF) <20% (site-reported)
7. Evidence of active endocarditis or other acute infections
8. Renal failure requiring continuous renal replacement therapy
9. Untreated clinically significant coronary artery disease requiring revascularization
10. Acute MI ≤30 days prior to the index procedure
11. Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
12. 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)
13. 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)
14. Severe (greater than 3+) mitral insufficiency (site-reported)
15. 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
16. Currently participating in another investigational drug or device study
17. Pregnancy or intend to become pregnant during study participation
18. Unicuspid aortic valve
19. Non-calcified aortic stenosis
20. 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
21. Isolated Aortic Insufficiency
22. Patients with a permanent pacemaker
23. Patients with pre-existing LBBB, RBBB and AV block 2 and 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biosensors PTV balloon catheter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During TAVI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful inflation and deflation of the study device during pre-dilatation	Rate of study devices successfully inflated and deflated	Measured during TAVI procedure
Balloon rupture during pre-dilatation	absolute number and percentages of balloon ruptures during pre-dilatation	measured during TAVI procedure
Number of pre-dilatations performed	Total number	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 during TAVI procedure
Successful inflation and deflation of the balloon during post-dilatation	Rate of study devices successfully inflated and deflated	measured during TAVI procedure
Number of post-dilatations performed	absolute number and percentages of post-dilatation	measured during TAVI procedure
Balloon rupture during post-dilatation	absolute number and percentages of balloon ruptures during post-dilatation	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 during TAVI procedure
Degree of aortic regurgitation (para-valvular) post-dilatation	absolute number and percentages of mild, moderate or severe aortic regurgitation	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 during TAVI procedure
Annular rupture	absolute number and percentages of annular ruptures	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	After TAVI procedure
All-cause mortality	absolute number and percentages of deaths	From enrollment until the patient is discharged (max. 7 days)
Cardiovascular mortality	absolute number and percentages of cardiovascular deaths	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	From enrollment until the patient is discharged (max. 7 days)
Procedure or valve related hospitalization	absolute number and percentages of hospitalizations	From TAVI procedure until the patient is discharged (max. 7 days)
Bleeding	absolute number and percentages of bleeding events	From enrollment until the patient is discharged (max. 7 days)
Major vascular complications	absolute number and percentages of major vascular complications	From enrollment until the patient is discharged (max. 7 days)
Major cardiac structural complications	absolute number and percentages of major cardiac structural complications	From enrollment until the patient is discharged (max. 7 days)
Conversion to open surgery	absolute number and percentages of conversions to open surgery	measured during TAVI procedure
Valve malposition (valve migration, valve embolization, ectopic valve deployment)	Absolute number and percentages of valve malpositions	measured during TAVI procedure

Collaborators and Investigators

• Sponsor: Biosensors Europe SA

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; TAVI; Balloon Aortic Valvuloplasty; PTV Balloon
• Additional Relevant MeSH Terms: Aortic Valve Disease; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Diseases
• Other Study ID Numbers: 24-EU-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No