This trial is related to replacement of diseased human aortic heart valve with an artificial TRIA aortic heart valve manufactured by Foldax

Phase 2

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2022/01/039144
• Lead Sponsor: FOLDAX INDIA PRIVATE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 month 12 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 cardiac procedure other than a CABG, or aortic root enlargement (allowed to

optimize the fit and placement of the TRIA Heart Valve if needed).

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 BSL > 300 mg/dl)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint <br/ ><br>Clinical Safety: The rates of adverse events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. <br/ ><br>a. Thromboembolism <br/ ><br>b. Valve Thrombosis <br/ ><br>c. Major Paravalvular leak <br/ ><br>d. Major Hemorrhage <br/ ><br>e. Endocarditis <br/ ><br>f. All-caused death <br/ ><br>g. Valve related death <br/ ><br>h. Valve-related reoperation <br/ ><br>i. Valve explant <br/ ><br>j. Hemorrhage <br/ ><br>k. All-cause reoperationTimepoint: 30 days(± 7 days) <br/ ><br>90 days(± 14 days) <br/ ><br>180 days(± 30 days) <br/ ><br>365 days(± 45 days)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints <br/ ><br>1. Stroke. <br/ ><br>2. Transient ischemic attack (TIA). <br/ ><br>3. ICU duration of stay. <br/ ><br>4. Ventilation time in hours defined as arrival time/date in recovery in hours <br/ ><br>and minutes to date and time extubated in hours and minutes. <br/ ><br>5. New/post-operative atrial fibrillation â?? confirmed on ECG after closure <br/ ><br>during initial or subsequent admission or at one-year review. <br/ ><br>6. Post procedure length of stay defined as the date and time in hours and <br/ ><br>minutes documented for arrival in the recovery unit to date and time in <br/ ><br>hours and minutes of discharge in hours and minutes. <br/ ><br>7. Readmission within 30 days of discharge. <br/ ><br>8. Hemolysis screen. <br/ ><br>9. Kansas City Cardiomyopathy Questionnaire <br/ ><br>10. Six-Minute Walk TestTimepoint: 30 days(± 7 days) <br/ ><br>90 days(± 14 days) <br/ ><br>180 days(± 30 days) <br/ ><br>365 days(± 45 days)