Status:
UNKNOWN
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
Lead Sponsor:
Foldax, Inc
Conditions:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
Detailed Description
The Foldax Tria Aortic Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single open are label non-ran...
Eligibility Criteria
Inclusion
- Is 45 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 1 year 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)
- Currently diagnosed as uncontrolled diabetes mellitus (Random BLS \> 300 mg/dl)
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06192706
Start Date
January 1 2022
End Date
September 1 2024
Last Update
January 5 2024
Active Locations (10)
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1
GCS Medical College
Ahmedabad, Gujarat, India, 380025
2
Epic Hospital
Ahmedabad, Gujarat, India, 380060
3
KEM Hospital
Mumbai, Maharashtra, India, 400012
4
Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, India, 400016