The Leaflex™ Brazilian Standalone Study

• Sponsor: Pi-cardia (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05052684
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: Leaflex™ Performer	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Leaflex™ Brazilian Standalone Study
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Leaflex™ Performer	Device: Leaflex™ Performer; A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.

Outcome Measures

Primary Outcome Measures

1. Change in aortic valve area [Baseline and up to 3 days post procedure]

   Assessed by echo Assessed by echo

Secondary Outcome Measures

1. Rate of all-cause mortality and all-cause stroke (VARC 2) [30 days post procedure]

   Composite

2. Rate of worsening of aortic regurgitation [Baseline and 30 days post procedure]

   By more than 1 grade

3. Rate of device related adverse events [Up to 12 months post procedure]

4. Change in 6 minute walk test [Baseline, 1, 6 and 12 months post procedure]

   Distance (meters)

5. Change in Quality of Life [Baseline, 1, 6 and 12 months post procedure]

   Kansas City Cardiomyopathy Questionnaire (KCCQ)

6. Change in Quality of Life [Baseline, 1, 6 and 12 months post procedure]

   EuroQol- 5 Dimension (EQ5D)

7. Change in aortic valve area [Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure]

   Assessed by echo

8. Change in pressure gradients [Baseline, up to 3 days, 30 days, 3, 6, 9 and 12 months post procedure]

   Assessed by echo

9. Change in pressure gradients [Pre-treatment, immediately post treatment (during procedure)]

   Measured invasively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• Severe 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto do Coração FMUSP Centro de Pesquisa	São Paulo		Brazil	05403-000

Sponsors and Collaborators

• Pi-cardia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pi-cardia
• ClinicalTrials.gov Identifier: NCT05052684
• Other Study ID Numbers: P02-CLN-019(BR)
• First Posted: Sep 22, 2021
• Last Update Posted: Jun 9, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Jun 9, 2022