PTV balloon used to open the aortic valve during TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Anders Jönsson
• Email: a.jonsson@biosensors.com
• Phone: 0041218048000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.