Status:
ACTIVE_NOT_RECRUITING
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
Lead Sponsor:
Foldax, Inc
Conditions:
Aortic Valve Disease
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 co...
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 unde...
Eligibility Criteria
Inclusion
- Is 18 years or older
- Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
- 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
- Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations
Exclusion
- Requires multiple valve replacement / repair
- Requires emergency surgery
- Has had prior valve surgery
- Requires a surgical procedure outside of the cardiac area
- Requires a cardiac procedure other than a CABG or root enlargement
- Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
- Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
- 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
- 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
- Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
- Has life expectancy to less than 12 months
- Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
- Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
- Echocardiographic left ventricular ejection fraction \<25%
- Echocardiographic evidence of an intra-cardiac thrombus or vegetation
- Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
- 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
- Has prior organ transplant or is currently an organ transplant candidate
- Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
- Pregnant, lactating or planning to become pregnant during the duration of participation in trial
- Currently incarcerated or unable to give voluntary informed consent
- Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
- Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
- Tests positive for an active infection with SARS-CoV-2 (COVID-19)
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03851068
Start Date
June 18 2019
End Date
December 1 2026
Last Update
September 13 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Vincent Hospital
Indianapolis, Indiana, United States, 46290
2
Ascension Via Christi St. Francis Hospital
Wichita, Kansas, United States, 67214
3
William Beaumont Hospital
Detroit, Michigan, United States, 48073
4
The Christ Hospital
Cincinnati, Ohio, United States, 84219