Clinical Investigation for the Foldax Tria Aortic Heart Valve- India

NCT06192706 | Unknown DMC

• 1 other identifier: Foldax CP-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Calcification; Aortic Valve Disease

Outcome Measures

Primary Outcomes (3)

• 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 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 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 Outcomes (10)

• Stroke

  12 months following patient enrollment

• Transient Ischemic Attack

  12 months following patient enrollment

• ICU Duration of Stay

  30 days post procedure

• Ventilation Time

  30 Days post procedure

• New Onset Atrial Fibrillation

  12 Months post procedure

Study Arms (1)

Tria Aortic Valve

EXPERIMENTAL

Patients receiving the Foldax Aortic Valve

Device: Foldax Tria Aortic Valve

Interventions

Foldax Tria Aortic Valve DEVICE

Aortic Valve Replacement

Tria Aortic Valve

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foldax, Inc: lead

Study Sites (10)

GCS Medical College

Ahmedabad, Gujarat, 380025, India

Location

Epic Hospital

Ahmedabad, Gujarat, 380060, India

Location

KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

Location

Six Sigma

Nashik, Maharashtra, 422007, India

Location

B.J. Medical College

Pune, Maharashtra, 411001, India

Location

SMS Hospital

Jaipur, Rajasthan, 302004, India

Location

Indo-US Hospital

Hyderabad, Telangana, 500016, India

Location

NRS Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

Fortis Hospital

Delhi, 110025, India

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve, Calcification of; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Kaushal Pandey, MBBS, MS

  Hinduja Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (10)