The Leaflex™ Early Feasibility Study

• Sponsor: Pi-cardia (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04636073
• Collaborator: (none)
• Enrollment: 15
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 29.5
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A prospective, multicenter, single-arm, early feasibility 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.

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: A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
• Actual Study Start Date: Jun 16, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

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 to 3 days]

   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 to 30 days]

   by greater than 1 grade

3. Rate of worsening of aortic regurgitation [Discharge to 30 days]

   by greater than 1 grade

4. Rate of device related adverse events [12 months]

5. Change in 6 minute walk test [1, 6 and 12 months]

   distance (meters)

6. Quality of Life Improvement [1, 6 and 12 months]

   measured by KCCQ

7. Quality of Life Improvement [1, 6 and 12 months]

   measured by EQ5D

8. Change in aortic valve area [30 day, 3, 6, 9, 12 months]

   assessed by echo

9. Change in pressure gradients [30 day, 3, 6, 9, 12 months]

   assessed by echo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with symptomatic, severe aortic stenosis who are operable, but 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:

• Inoperable for emergency surgery.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlantic Health System Hospital Corp - Morristown Medical Center	Morristown	New Jersey	United States	07960
2	Columbia University Medical Center/NYPH	New York	New York	United States	10032
3	UPMC Pinnacle	Harrisburg	Pennsylvania	United States	17101

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: NCT04636073
• Other Study ID Numbers: P02-CLN-028
• First Posted: Nov 19, 2020
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Jul 29, 2022