Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement (FOLDAX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04717570|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Disease Mitral Valve Stenosis Mitral Valve Failure||Device: Foldax TRIA Mitral Valve||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients will receive the study device|
|Masking:||None (Open Label)|
|Official Title:||Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2025|
Experimental: TRIA Mitral Valve
Patients receiving the Foldax Mitral Valve
Device: Foldax TRIA Mitral Valve
Mitral Valve Replacement
- Primary Safety Endpoints [ Time Frame: 12 months following patient enrollment completion ]Adverse Event (AE) rates for valve related early and late complications : thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, endocarditis, structural valve deterioration, nonstructural valve dysfunction, valve related hemolysis, all cause death, valve related reoperation, valve explant, and valve related death. Results are visually compared to event rates reported in the literature.
- Primary Effectiveness Endpoints- Change in Hemodynamic Performance [ Time Frame: 12 months following patient enrollment completion ]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.
- Clinical Effectiveness: Change in New York Heart Association Assessment [ Time Frame: 12 months following patient enrollment completion ]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.
- Number of Participants with Stroke [ Time Frame: 5 years following patient enrollment ]Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
- Number of Participants with Transient Ischemic Attack [ Time Frame: 5 years following patient enrollment ]Assessment of patient having a TIA as verified by imaging and or physical exam
- Number of Participants with Migration of the TRIA valve [ Time Frame: 5 years following patient enrollment ]Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
- ICU Duration of Stay [ Time Frame: 30 days post patient enrollment ]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.
- Ventilation Time [ Time Frame: 30 days post patient enrollment ]Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
- New Onset Atrial Fibrillation [ Time Frame: 12 months post patient enrollment ]New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
- Readmission within 30 days of discharge [ Time Frame: 30 days post patient discharge date ]Patient readmission to the hospital post discharge measured by date/time
- Post Procedure length of stay [ Time Frame: 30 days post patient enrollment ]l. Post procedure length of stay defined as the time/date documented for arrival in the recovery unit to date/ time of discharge in hours and minutes.
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months post patient enrollment ]Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status.
- Six Minute Walk Test [ Time Frame: 12 months post patient enrollment ]Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717570
|Contact: Carlyn Sander, BS, BSNfirstname.lastname@example.org|
|United States, Indiana|
|St. Vincent Hospital||Recruiting|
|Carmel, Indiana, United States, 46260|
|Contact: Cheree Slusher 317-582-6115 email@example.com|
|Principal Investigator: Dave Heimansohn, MD|
|United States, Kansas|
|Ascension Via Christi St. Francis||Recruiting|
|Wichita, Kansas, United States, 67226|
|Contact: Lindsey Steele, R.T. 316-219-4125 firstname.lastname@example.org|
|Principal Investigator: Bassem Chahab, MD|
|Sub-Investigator: Brett Grizzell, MD|
|United States, Ohio|
|The Christ Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Susie Frakes, BSN 513-585-1777 email@example.com|
|Principal Investigator: Geoffrey Answini, MD|
|Study Chair:||Frank Shannon, MD||Beaumont Hospital|