Early Feasibility Study for the Foldax Tria Aortic Heart Valve

NCT03851068 | Active Not Recruiting DMC FDA Device

• 1 other identifier: FOLDAX CP-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (4)

• Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments

  The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis

  12 months following patient enrollment completion

• Primary Safety Endpoints: Surgical Valve Events Rate Assessment

  The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death

  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 (9)

• Secondary Endpoints: Stroke

  5 years following patient enrollment

• Secondary Endpoint: Transient Ischemic Attack

  5 Years following patient enrollment

• Secondary Endpoint: ICU Duration of Stay

  30 days post procedure

• Secondary Endpoint: Ventilation Time

  30 Days post procedure

• Secondary Endpoint: New Onset Atrial Fibrillation

  12 Months post procedure

Study Arms (1)

Tria Aortic Valve

EXPERIMENTAL

Patients receiving the Foldax Tria Aortic Valve

Device: Foldax Tria Aortic Valve

Interventions

Foldax Tria Aortic Valve DEVICE

Aortic Valve Replacement

Tria Aortic Valve

Eligibility Criteria

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

You may qualify if:

• Is 18 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 5 years 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 (5)

St. Vincent Hospital

Indianapolis, Indiana, 46290, United States

Location

Ascension Via Christi St. Francis Hospital

Wichita, Kansas, 67214, United States

Location

William Beaumont Hospital

Detroit, Michigan, 48073, United States

Location

The Christ Hospital

Cincinnati, Ohio, 84219, United States

Location

OhioHealth Riverside

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Frank Shannon, MD

  Beaumont 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: February 14, 2019
• First Posted: February 22, 2019
• Study Start: June 18, 2019
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)