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

NCT06816485 | Recruiting DMC

• 1 other identifier: 24-EU-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 9

Brief 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. 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. 1.Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation.
2. 2.Will be followed up until discharge or up to 7 days, whichever happens first.

Conditions

Aortic Diseases

Keywords

PTV Balloon; TAVI; Aortic Valve Stenosis; Balloon Aortic Valvuloplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Successful inflation and deflation of the study device during pre-dilatation

  Measured during TAVI procedure

• Balloon rupture during pre-dilatation

  measured during TAVI procedure

• Number of pre-dilatations performed

  Measured during TAVI procedure

• Need for post-dilatation and reason (under expansion, PVL, other)

  measured during TAVI procedure

• Successful inflation and deflation of the balloon during post-dilatation

  measured during TAVI procedure

Study Arms (1)

Biosensors PTV balloon catheter

EXPERIMENTAL

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

Device: PTV (Percutaneous Transcatheter Valvuloplasty) Balloon

Interventions

PTV (Percutaneous Transcatheter Valvuloplasty) Balloon 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.

Biosensors PTV balloon catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Biosensors Europe SA: lead

Study Sites (9)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Spain

RECRUITING

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid (HCUV)

Valladolid, 47003, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Diseases; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Anders Jönsson

CONTACT

0041218048000; a.jonsson@biosensors.com

Diana Schuette

CONTACT

00447970942022; d.schuette@biosensors.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 10, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

ES (9)