NCT06191718

Brief Summary

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

December 20, 2023

Last Update Submit

December 20, 2023

Conditions

Mitral Valve DiseaseMitral RegurgitationMitral StenosisMitral Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

  • Primary Safety Endpoints

    Serious Adverse Event (SAE) rates for any valve related events. Results are compared descriptively to event rates reported in the literature.

    12 months after last patient enrollment

  • Primary Effectiveness Endpoint- Change in Hemodynamic Performance

    Hemodynamic performance parameters are mmHG mean gradient, peak gradient, and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (mean/peak gradient and Effective Orifice Area (EOA)) at one year based on literature reports for surgical mitral valve replacement.

    12 months after last patient enrollment

  • Clinical Effectiveness Endpoint- Change in New York Heart Association 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 after last patient enrollment

Secondary Outcomes (8)

  • Number of Participants with Stroke

    1 year following patient enrollment

  • Number of Participants with Structural Valve Deterioration (SVD)

    1 year following patient enrollment

  • Number of Participants with Transient Ischemic Attack

    1 year following patient enrollment

  • ICU Duration of Stay

    30 Days post patient enrollment

  • Ventilation Time

    30 Days post patient enrollment

  • +3 more secondary outcomes

Study Arms (1)

Tria Mitral Valve

EXPERIMENTAL

Patients receiving the Foldax Mitral Valve

Device: Mitral Valve Replacement

Interventions

Mitral Valve ReplacementDEVICE

Foldax Mitral Valve Replacement

Tria Mitral Valve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is 18 years or older
  • Is a candidate for mitral valve replacement with cardiopulmonary bypass
  • Is a candidate for mitral valve replacement due to severe mitral valve disease
  • No contraindication for anticoagulation treatment
  • Willing and able to comply with protocol requirements

You may not qualify if:

  • Requires valve replacement other than mitral
  • Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
  • Required concomitant cardiovascular procedures except for CABG and/or COX-MAZE if approved by the screening committee
  • Requires emergency surgery
  • Requires other planned surgery within 12 months of valve replacement
  • Active endocarditis or active myocarditis
  • Exhibits left ventricular ejection fraction \</= 20% as validated by diagnostic procedure prior to planned valve surgery
  • Acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment
  • Life expectancy of less than 12 months
  • Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies)
  • Myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment
  • Aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications
  • Renal insufficiency as determined by creatinine (S-CR) level as \>/= 2.0 mg/dl or end stage renal disease requiring chronic dialysis at screening visit
  • Results for the following blood tests are not within normal limits: D-Dimer, Basic Metabolic Panel Liver enzymes, Coagulation Profile - platelets, APTT, INR, Fibrinogen, C-reactive protein (HSCRP) and ESR, and Troponin levels
  • Hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dL, platelet count of \<100,000 cells/µL, or WBC \<4,000 cells/µL; coagulation profile must not be outside of normal limits
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Related Publications (1)

  • George I, Rao DP, Jain A, Ascione G, Sharma M, Meharwal ZS, Sarkar B, Kochar N, Gan MD, Shastri N, Runt J, Whisenant B, Wilson B, Kiser A, Leon MB, Pandey K. 1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve: Insights Into New Technology. J Am Coll Cardiol. 2025 Aug 19;86(7):515-526. doi: 10.1016/j.jacc.2025.06.017. Epub 2025 Jun 27.

    PMID: 40589299DERIVED

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

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 20, 2023

First Posted

January 5, 2024

Study Start

March 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IN(10)