A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex* Performer

Withdrawn

• Conditions: Aortic Stenosis; narrowing of the aortic valve; 10046973

• Registration Number: NL-OMON55148
• Lead Sponsor: Pi-Cardia Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Male and female age >18 years.
2. Patient with severe aortic stenosis.
3. Senile degenerative severe aortic valve stenosis with echocardiography
derived criteria: mean gradient > 40 mmHg OR jet velocity > 4.0 m/s OR AVA *
1.0 cm2 OR AVA index (AVAi) * 0.6 cm2/m2.
4. NYHA Functional Class * 2 OR exercise test that demonstrates a limited
exercise capacity, abnormal BP response, or arrhythmia.
5. Not recommended by the heart team for immediate treatment with surgical or
transcatheter aortic valve replacement.

Exclusion Criteria

1. Aortic valve is unicuspid, bicuspid, or non-calcified.
2. Severe aortic regurgitation (>2+).
3. An exceptional aortic valve leaflet Calcium morphology, as determined by the
CT Core Lab.
4. Pre-existing mechanical or bioprosthetic aortic or mitral valve.
5. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath.
6. Coronary disease that, in the opinion of the heart team, should be treated;
or treatment of coronary disease * 1 month prior to index procedure.
7. Aortic balloon valvuloplasty * 3 months prior to index procedure.
8. CVA or TIA * 12 months prior to index procedure.
9. History of a myocardial infarction (MI) * 6 weeks prior to index procedure.
10. Previous or current bacterial endocarditis.
11. Ongoing severe infection or sepsis.
12. Life expectancy * 12 months post index procedure due to morbidity other
than aortic valve related.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary performance endpoint - change in AVA measured by echocardiography<br /><br>before treatment with the Leaflex* (within 7 days prior to index procedure) and<br /><br>after treatment with the Leaflex* (within 3 days post index procedure).<br /><br>Main safety endpoints:<br /><br>* Composite rates of all-cause mortality and stroke (according to VARC-2<br /><br>definitions48) through 30 days post the procedure.<br /><br>* Worsening of aortic regurgitation (AR) by >1 grade assessed by<br /><br>echocardiography at 30 days post the procedure compared to before treatment<br /><br>with the Leaflex* (within 7 days prior to treatment) and to after treatment<br /><br>with the Leaflex* (within three days post treatment).<br /><br>* Assessment of all adverse events from enrollment up to 12 months post<br /><br>procedure.</p><br>