The Leaflex™ Standalone Study Protocol

Aortic Valve Stenosis Clinical Trial

Official title:

The Leaflex™ Standalone Study Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04649099
• Other study ID #: P02-CLN-019
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Pi-cardia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.

• Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.

Exclusion Criteria:

• Moderate or greater aortic regurgitation.

• Anatomic contraindications.

• Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease = 1 month prior to index procedure.

• Aortic balloon valvuloplasty = 3 months prior to index procedure.

• Stroke = 12 months prior to index procedure.

• History of a myocardial infarction = 6 weeks prior to index procedure.

• Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy.

• Hemodynamic instability.

• Hypertrophic cardiomyopathy with obstruction.

• Left ventricle ejection fraction <30%.

• Ongoing severe infection, including endocarditis, or sepsis.

• Life expectancy = 12 months.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Leaflex™ Performer
A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

Locations

Country	Name	City	State
Hungary	Gottsegen Gyorgy Hungarian Institute of Cardiology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Pi-cardia

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aortic valve area	assessed by echo	Baseline to 3 days
Secondary	Rate of all-cause mortality and all-cause stroke (VARC 2)	Composite	30 days post procedure
Secondary	Rate of worsening of aortic regurgitation	by greater than 1 grade	Baseline to 30 days
Secondary	Rate of device related adverse events		12 months
Secondary	Change in 6 minute walk test	distance (meters)	1, 6 and 12 months
Secondary	Quality of Life Improvement	KCCQ	1, 6 and 12 months
Secondary	Quality of Life Improvement	EQ5D	1, 6 and 12 months
Secondary	Change in aortic valve area	assessed by echo	30 days, 3, 6, 9 and 12 months
Secondary	Change in pressure gradients	assessed by echo	30 days, 3, 6, 9 and 12 months