Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Overview

About this study

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age > 18 and ≤ 85 years old.
  • Symptomatic severe (Stage D) functional, tricuspid regurgitation (per applicable guidelines).
  • Symptomatic despite medical therapy; patient must be on diuretic therapy.
  • The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid repair.
  • Patient is willing and able to comply with all specified study evaluations and provides written informed consent.

Exclusion Criteria: 

  • Echocardiographic/CT parameters (any of the following): 
    • Vessel access or right heart anatomy precluding proper device introduction, deployment and function;
    • LVEF < 30%;
    • Severe right ventricular dysfunction as assessed by the core lab;
    • Patients with systolic pulmonary artery pressure > 60 mmHg.
  • Primary tricuspid disease (e.g., rheumatic, myxomatous degeneration, tricuspid valve prolapse, tricuspid stenosis).
  • Previous tricuspid leaflet repair or tricuspid valve replacement.
  • Presence of two or more trans-tricuspid leads or any single trans-tricuspid lead:
    • Precluding proper placement of or interferes with device;
    • Implanted within the last 180 days;
    • With pacemaker dependency.
  • Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
  • Active endocarditis within 90 days of the scheduled implant.
  • Significant pericardial effusion.
  • Intra-cardiac masses, thrombi or vegetation.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Recurrent (> 2 per 12 months) hospitalizations or ER visit for COPD exacerbation.
  • MI or known unstable angina within 30 days prior to the index procedure.
  • Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure, or any dual anti-platelet therapy (DAPT) requirement which cannot be interrupted for 7 days.
  • Any cardiac surgery, within 3 months prior to procedure.
  • Hemodynamic instability or on IV inotropes within 30 days of the scheduled implant.
  • Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg).
  • Cerebrovascular Accident (CVA) or TIA within the past 30 days.
  • Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 or patient is on chronic dialysis.
  • Any physical impairment which limits the patient’s capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition).
  • Significant frailty (i.e., Katz Index of Independence in Activities of Daily Living (ADL) ≤ 2) within 90 days of scheduled implant procedure.
  • Chronic liver disease with a MELD score of 12 or greater.
  • Continuous home oxygen for primary severe COPD.
  • Chronic anemia (Hb < 9 g/L) not corrected by transfusion .
  • Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3).
  • Bleeding disorders or hypercoagulable state.
  • Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant .
  • Cardiac cachexia.
  • Contraindication to anticoagulants or antiplatelet agents.
  • Currently or history of IV drug use.
  • Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
  • Patients in whom transesophageal echocardiography is contraindicated.
  • Known allergy to cobalt chromium, nitinol, titanium or contrast agents that cannot be adequately pre-medicated.
  • Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
  • Impaired judgment and/or is undergoing emergent or urgent treatment for tricuspid insufficiency.
  • Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
  • Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
  • Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient’s ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
  • Patient is under guardianship.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available