Clinical trial NCT03851068: Early Feasibility Study for the Foldax Tria Aortic Heart Valve
Official title: Early Feasibility Study for the Foldax Tria Aortic Heart Valve
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Lead sponsor: Foldax, Inc
Sponsor class: INDUSTRY
First posted: 2019-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Detailed description: The Foldax Polymer Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 40 patients. These patients will be followed up to 5 years after implantation.

Eligibility criteria: Inclusion Criteria:

1. Is 18 years or older
2. Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
4. Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Exclusion Criteria:

1. Requires multiple valve replacement / repair
2. Requires emergency surgery
3. Has had prior valve surgery
4. Requires a surgical procedure outside of the cardiac area
5. Requires a cardiac procedure other than a CABG or root enlargement
6. Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
7. Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
8. Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit
9. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery
10. Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
11. Has life expectancy to less than 12 months
12. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
13. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
14. Echocardiographic left ventricular ejection fraction \<25%
15. Echocardiographic evidence of an intra-cardiac thrombus or vegetation
16. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
17. Documented leukopenia (WBC \< 4.0 x 103/µL), acute anemia (Hgb \< 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count \< 100 x103/µL) or history of bleeding diathesis or coagulopathy
18. Has prior organ transplant or is currently an organ transplant candidate
19. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
20. Pregnant, lactating or planning to become pregnant during the duration of participation in trial
21. Currently incarcerated or unable to give voluntary informed consent
22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
23. Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
24. Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Primary outcomes:
measure: Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments
timeFrame: 12 months following patient enrollment completion
measure: Primary Safety Endpoints: Surgical Valve Events Rate Assessment
timeFrame: 12 months following patient enrollment completion
measure: Primary Effectiveness Endpoint: Hemodynamic Performance Assessment
timeFrame: 12 months following patient enrollment completion
measure: Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment
timeFrame: 12 months following patient enrollment completion
Secondary outcomes:
measure: Secondary Endpoints: Stroke
timeFrame: 5 years following patient enrollment
measure: Secondary Endpoint: Transient Ischemic Attack
timeFrame: 5 Years following patient enrollment
measure: Secondary Endpoint: ICU Duration of Stay
timeFrame: 30 days post procedure
measure: Secondary Endpoint: Ventilation Time
timeFrame: 30 Days post procedure
measure: Secondary Endpoint: New Onset Atrial Fibrillation
timeFrame: 12 Months post procedure
measure: Secondary Endpoint: Length of Stay in Hospital
timeFrame: 30 days post procedure
measure: Secondary Endpoint: Readmission
timeFrame: 30 days post discharge
measure: Secondary Endpoint: Hemolysis screen
timeFrame: 12 months post procedure
measure: Secondary Endpoint: Change in Quality of Life (QOL)
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Wichita
country: United States
facility: Ascension Via Christi St. Francis Hospital
state: Kansas
city: Detroit
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside
state: Ohio
Study officials:
affiliation: Beaumont Hospital
name: Frank Shannon, MD
role: PRINCIPAL_INVESTIGATOR
References: