Clinical trial NCT06816485: INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Official title: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Diseases
Keywords: PTV Balloon
TAVI
Aortic Valve Stenosis
Balloon Aortic Valvuloplasty
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: During TAVI procedure
Secondary outcomes:
measure: Successful inflation and deflation of the study device during pre-dilatation
timeFrame: Measured during TAVI procedure
measure: Balloon rupture during pre-dilatation
timeFrame: measured during TAVI procedure
measure: Number of pre-dilatations performed
timeFrame: Measured during TAVI procedure
measure: Need for post-dilatation and reason (under expansion, PVL, other)
timeFrame: measured during TAVI procedure
measure: Successful inflation and deflation of the balloon during post-dilatation
timeFrame: measured during TAVI procedure
measure: Number of post-dilatations performed
timeFrame: measured during TAVI procedure
measure: Balloon rupture during post-dilatation
timeFrame: measured during TAVI procedure
measure: Rate of conduction system abnormalities induced by post-dilatation
timeFrame: measured during TAVI procedure
measure: Degree of aortic regurgitation (para-valvular) post-dilatation
timeFrame: measured during TAVI procedure
measure: New onset conduction disorders and arrhythmias at any other times during the procedure
timeFrame: measured during TAVI procedure
measure: Annular rupture
timeFrame: measured during TAVI procedure
measure: Usability assessment of the device per case
timeFrame: After TAVI procedure
measure: All-cause mortality
timeFrame: From enrollment until the patient is discharged (max. 7 days)
measure: Cardiovascular mortality
timeFrame: From enrollment until the patient is discharged (max. 7 days)
measure: Neurological events (All stroke, stroke disability, transient ischemic attack)
timeFrame: From enrollment until the patient is discharged (max. 7 days)
measure: Procedure or valve related hospitalization
timeFrame: From TAVI procedure until the patient is discharged (max. 7 days)
measure: Bleeding
timeFrame: From enrollment until the patient is discharged (max. 7 days)
measure: Major vascular complications
timeFrame: From enrollment until the patient is discharged (max. 7 days)
measure: Major cardiac structural complications
timeFrame: From enrollment until the patient is discharged (max. 7 days)
measure: Conversion to open surgery
timeFrame: measured during TAVI procedure
measure: Valve malposition (valve migration, valve embolization, ectopic valve deployment)
timeFrame: measured during TAVI procedure
Other outcomes:
Locations:
Study officials:
References: