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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06192706
Other study ID # Foldax CP-003
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date September 1, 2024

Study information

Verified date December 2023
Source Foldax, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. These patients will follow the study schedule for 1 year after implantation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: 1. Is 45 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 1 year 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) 25. Currently diagnosed as uncontrolled diabetes mellitus (Random BLS > 300 mg/dl)

Study Design


Intervention

Device:
Foldax Tria Aortic Valve
Aortic Valve Replacement

Locations

Country Name City State
India Epic Hospital Ahmedabad Gujarat
India GCS Medical College Ahmedabad Gujarat
India Fortis Hospital Delhi
India Indo-US Hospital Hyderabad Telangana
India SMS Hospital Jaipur Rajasthan
India NRS Medical College and Hospital Kolkata West Bengal
India Hinduja Hospital and Medical Research Centre Mumbai Maharashtra
India KEM Hospital Mumbai Maharashtra
India Six Sigma Nashik Maharashtra
India B.J. Medical College Pune Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Foldax, Inc

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Safety Endpoints: Clinical Outcomes Event Assessment The rate of adverse events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature: a) thromboembolism, b) valve thrombosis, c) major paravalvular leak, d) major hemorrhage, e) endocarditis, f) all-caused death, g) valve related death, h) valve related reoperation, i) valve explant, j) hemorrhage, k) all-cause reoperation 12 months following patient enrollment completion
Primary Primary Effectiveness Endpoint: Hemodynamic Performance Assessment Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement. 12 months following patient enrollment completion
Primary Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. 12 months following patient enrollment completion
Secondary Stroke Assessment of patient experiencing a stroke verified by imaging and or physical exam 12 months following patient enrollment
Secondary Transient Ischemic Attack Assessment of patient having a TIA verified by imaging and or physical exam 12 months following patient enrollment
Secondary ICU Duration of Stay Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes. 30 days post procedure
Secondary Ventilation Time Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes 30 Days post procedure
Secondary New Onset Atrial Fibrillation New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review 12 Months post procedure
Secondary Length of Stay in Hospital Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes. 30 Days post procedure
Secondary Readmission Patient readmission to the hospital post discharge measured by date/time 30 Days post procedure
Secondary Hemolysis screen Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments 12 Months post procedure
Secondary Change in Quality of Life (QOL) Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire 12 Months post procedure
Secondary Six Minute Walk Test (6MWT) Change in distance walked during a 6MWT 12 months post procedure
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