Clinical trial NCT06192706: Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
Official title: Clinical Investigation for the Foldax Tria Aortic Heart Valve India
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Aortic Valve Calcification
Aortic Valve Disease
Lead sponsor: Foldax, Inc
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 45
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 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-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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary Safety Endpoints: Clinical Outcomes Event 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: Stroke
timeFrame: 12 months following patient enrollment
measure: Transient Ischemic Attack
timeFrame: 12 months following patient enrollment
measure: ICU Duration of Stay
timeFrame: 30 days post procedure
measure: Ventilation Time
timeFrame: 30 Days post procedure
measure: New Onset Atrial Fibrillation
timeFrame: 12 Months post procedure
measure: Length of Stay in Hospital
timeFrame: 30 Days post procedure
measure: Readmission
timeFrame: 30 Days post procedure
measure: Hemolysis screen
timeFrame: 12 Months post procedure
measure: Change in Quality of Life (QOL)
timeFrame: 12 Months post procedure
measure: Six Minute Walk Test (6MWT)
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: GCS Medical College
state: Gujarat
city: Ahmedabad
country: India
facility: Epic Hospital
state: Gujarat
city: Mumbai
country: India
facility: KEM Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Hinduja Hospital and Medical Research Centre
state: Maharashtra
city: Nashik
country: India
facility: Six Sigma
state: Maharashtra
city: Pune
country: India
facility: B.J. Medical College
state: Maharashtra
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Hyderabad
country: India
facility: Indo-US Hospital
state: Telangana
city: Kolkata
country: India
facility: NRS Medical College and Hospital
state: West Bengal
city: Delhi
country: India
facility: Fortis Hospital
Study officials:
affiliation: Hinduja Hospital
name: Kaushal Pandey, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: