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

Biosensors Europe SA93 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Spain

RECRUITING

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid (HCUV)

Valladolid, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: During TAVI procedure

Secondary Outcomes

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

Rate of study devices successfully inflated and deflated

Time frame: Measured during TAVI procedure

Balloon rupture during pre-dilatation

absolute number and percentages of balloon ruptures during pre-dilatation

Time frame: measured during TAVI procedure

Number of pre-dilatations performed

Total number

Time frame: Measured during TAVI procedure

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

absolute number and percentages of post-dilatation and reason why

Time frame: measured during TAVI procedure

Successful inflation and deflation of the balloon during post-dilatation

Rate of study devices successfully inflated and deflated

Time frame: measured during TAVI procedure

Number of post-dilatations performed

absolute number and percentages of post-dilatation

Time frame: measured during TAVI procedure

Balloon rupture during post-dilatation

absolute number and percentages of balloon ruptures during post-dilatation

Time frame: 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.

Time frame: measured during TAVI procedure

Degree of aortic regurgitation (para-valvular) post-dilatation

absolute number and percentages of mild, moderate or severe aortic regurgitation

Time frame: 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

Time frame: measured during TAVI procedure

Annular rupture

absolute number and percentages of annular ruptures

Time frame: 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

Time frame: After TAVI procedure

All-cause mortality

absolute number and percentages of deaths

Time frame: From enrollment until the patient is discharged (max. 7 days)

Cardiovascular mortality

absolute number and percentages of cardiovascular deaths

Time frame: 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

Time frame: From enrollment until the patient is discharged (max. 7 days)

Procedure or valve related hospitalization

absolute number and percentages of hospitalizations

Time frame: From TAVI procedure until the patient is discharged (max. 7 days)

Bleeding

absolute number and percentages of bleeding events

Time frame: From enrollment until the patient is discharged (max. 7 days)

Major vascular complications

absolute number and percentages of major vascular complications

Time frame: From enrollment until the patient is discharged (max. 7 days)

Major cardiac structural complications

absolute number and percentages of major cardiac structural complications

Time frame: From enrollment until the patient is discharged (max. 7 days)

Conversion to open surgery

absolute number and percentages of conversions to open surgery

Time frame: measured during TAVI procedure

Valve malposition (valve migration, valve embolization, ectopic valve deployment)

Absolute number and percentages of valve malpositions

Time frame: measured during TAVI procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts