Clinical trial NCT04649099: The Leaflex™ Standalone Study Protocol
Official title: The Leaflex™ Standalone Study Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Pi-cardia
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study includes two stages:

* Exploratory stage - an exploratory examination of patients with an aim to streamline the study procedures, to reach a safe and consistent result, to evaluate the target patient population and adapt scoring protocol to optimize efficacy of the Leaflex™ procedure. The protocol does not include a formal staticstical analysis of the results of subjects enrolled in this stage.
* Confirmatory - confirmatory analysis with an aim to demonstrate the Leaflex™ safety and performance.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in aortic valve area
timeFrame: Baseline to 3 days
Secondary outcomes:
measure: Rate of all-cause mortality and all-cause stroke (VARC 2)
timeFrame: 30 days post procedure
measure: Rate of worsening of aortic regurgitation
timeFrame: Baseline to 30 days
measure: Rate of device related adverse events
timeFrame: 12 months
measure: Change in 6 minute walk test
timeFrame: 1, 6 and 12 months
measure: Quality of Life Improvement
timeFrame: 1, 6 and 12 months
measure: Quality of Life Improvement
timeFrame: 1, 6 and 12 months
measure: Change in aortic valve area
timeFrame: 30 days, 3, 6, 9 and 12 months
measure: Change in pressure gradients
timeFrame: 30 days, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy Hungarian Institute of Cardiology
Study officials:
References: