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

Launched by BIOSENSORS EUROPE SA · Feb 6, 2025

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ClinConnect Summary

The INFLATE Study is a clinical trial that aims to test a new device called a PTV Balloon, which is designed to help open a narrowed heart valve in patients who need a new heart valve replacement. This study will specifically look at how safe and effective the balloon is in preventing new heart conduction problems in patients who are undergoing a procedure called TAVI (Transcatheter Aortic Valve Implantation) for severe aortic stenosis, a condition where the heart's aortic valve becomes too narrow, making it hard for the heart to pump blood.

To be eligible for the trial, participants must be at least 18 years old and have severe narrowing of the aortic valve that causes symptoms. They should also be planned for a specific type of TAVI procedure. Participants will have the PTV Balloon used during their procedure and will be monitored for up to seven days after, or until they leave the hospital. It's important to note that there are specific health conditions that would exclude someone from participating, such as certain heart or vascular diseases. This study is currently not recruiting participants, but it offers an opportunity to help advance treatment for patients with aortic valve issues.

Gender

ALL

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