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

NCT ID: NCT06816485

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Diseases

Keywords

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PTV Balloon TAVI Aortic Valve Stenosis Balloon Aortic Valvuloplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biosensors PTV balloon catheter

Patients suffering from a severe aortic stenosis and scheduled for a TAVI.

Group Type EXPERIMENTAL

PTV (Percutaneous Transcatheter Valvuloplasty) Balloon

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosensors Europe SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status RECRUITING

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clínico Universitario de Valladolid (HCUV)

Valladolid, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Anders Jönsson

Role: CONTACT

Phone: 0041218048000

Email: [email protected]

Diana Schuette

Role: CONTACT

Phone: 00447970942022

Email: [email protected]

Facility Contacts

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Rafael Romaguera

Role: primary

Soledad Ojeda Pineda

Role: primary

Antonio Gomez Menchero

Role: primary

Jorge Sanz Sanchez

Role: primary

Ignacio Amat Santos

Role: primary

Other Identifiers

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24-EU-01

Identifier Type: -

Identifier Source: org_study_id