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

Not Applicable

Not yet recruiting

• Conditions: Aortic Diseases

• Registration Number: NCT06816485
• Lead Sponsor: Biosensors Europe SA

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. 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

Not available

Study Timeline

• Study First Submitted: 2025-01-23
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-06
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Number of post-dilatations performed	measured during TAVI procedure	absolute number and percentages of post-dilatation
Number of pre-dilatations performed	Measured during TAVI procedure	Total number
Balloon rupture during post-dilatation	measured during TAVI procedure	absolute number and percentages of balloon ruptures during post-dilatation
Degree of aortic regurgitation (para-valvular) post-dilatation	measured during TAVI procedure	absolute number and percentages of mild, moderate or severe aortic regurgitation
Procedure or valve related hospitalization	From TAVI procedure until the patient is discharged (max. 7 days)	absolute number and percentages of hospitalizations
Major vascular complications	From enrollment until the patient is discharged (max. 7 days)	absolute number and percentages of major vascular complications
Balloon rupture during pre-dilatation	measured during TAVI procedure	absolute number and percentages of balloon ruptures during pre-dilatation
Successful inflation and deflation of the study device during pre-dilatation	Measured during TAVI procedure	Rate of study devices successfully inflated and deflated
Need for post-dilatation and reason (under expansion, PVL, other)	measured during TAVI procedure	absolute number and percentages of post-dilatation and reason why
Successful inflation and deflation of the balloon during post-dilatation	measured during TAVI procedure	Rate of study devices successfully inflated and deflated
Rate of conduction system abnormalities induced by post-dilatation	measured during TAVI procedure	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.
Usability assessment of the device per case	After TAVI procedure	Absolute number and percentages within each category of the below scale: Unsuccessful Poor Average Good Excellent
New onset conduction disorders and arrhythmias at any other times during the procedure	measured during TAVI procedure	absolute number and percentages of new onset conduction disorders and arrhythmias
Annular rupture	measured during TAVI procedure	absolute number and percentages of annular ruptures
All-cause mortality	From enrollment until the patient is discharged (max. 7 days)	absolute number and percentages of deaths
Cardiovascular mortality	From enrollment until the patient is discharged (max. 7 days)	absolute number and percentages of cardiovascular deaths
Bleeding	From enrollment until the patient is discharged (max. 7 days)	absolute number and percentages of bleeding events
Neurological events (All stroke, stroke disability, transient ischemic attack)	From enrollment until the patient is discharged (max. 7 days)	absolute number and percentages of neurological events
Major cardiac structural complications	From enrollment until the patient is discharged (max. 7 days)	absolute number and percentages of major cardiac structural complications
Conversion to open surgery	measured during TAVI procedure	absolute number and percentages of conversions to open surgery
Valve malposition (valve migration, valve embolization, ectopic valve deployment)	measured during TAVI procedure	Absolute number and percentages of valve malpositions