PTV balloon used to open the aortic valve during TAVI

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

This will test a new PTV balloon used during TAVI in adults with severe aortic stenosis to see how often it causes new heart conduction problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biosensors Europe SA (Industry-sponsored)
• Locations: 9 sites (Barcelona and 8 other locations)
• Trial ID: NCT06816485 on ClinicalTrials.gov

What this trial studies

This device study uses an investigational PTV balloon for pre-dilatation and, if needed, post-dilatation during transfemoral TAVI in adults with severe calcific aortic stenosis. Participants will undergo the planned TAVI procedure with the PTV balloon and be monitored closely for new conduction abnormalities. The main outcome is the percentage of patients who develop new heart conduction problems after balloon use, with follow-up until hospital discharge or up to seven days. The trial is sponsored by Biosensors Europe SA and is being conducted at three tertiary hospitals in Spain.

Who should consider this trial

Good fit: Adults (age ≥18) with symptomatic severe calcific native aortic stenosis meeting hemodynamic criteria, judged eligible for transfemoral TAVI by the local Heart Team, who can give informed consent and comply with follow-up.

Not a fit: Patients with an aortic annulus outside the 16–30 mm range, intracardiac thrombus, severe aortic or ilio-femoral disease that precludes safe TAVI, or other listed exclusions are unlikely to benefit from this device in the study.

Why it matters

Potential benefit: If successful, the PTV balloon could make pre- and post-dilatation during TAVI safer by reducing procedure-related complications or improving valve deployment control.

How similar studies have performed: Balloon pre-dilatation and post-dilatation are established techniques in TAVI, but this specific PTV balloon is a novel device and device-specific safety data are limited.

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

Where this trial is running

Barcelona and 8 other locations

• 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)

Study contacts

• Study coordinator: Anders Jönsson

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