Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ACTIVE_NOT_RECRUITING

Clinical Study of Edwards Cardioband FIT Valve Repair System

Lead Sponsor:

Edwards Lifesciences

Conditions:

Tricuspid Regurgitation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Clinical Study of the Edwards Cardioband FIT Repair System

Detailed Description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System

Eligibility Criteria

Inclusion

  • Key
  • Tricuspid regurgitation (moderate or greater)
  • Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
  • The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction
  • Patient is willing and able to comply with all specified study evaluations and provides written informed consent
  • Key

Exclusion

  • Patients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:
  • Patients in whom transesophageal echocardiography is contraindicated or cannot be completed.
  • Patients in whom tricuspid valve anatomy is not evaluable by TTE or TEE
  • Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), polyester, or contrast media.
  • Previous tricuspid valve repair or replacement with device in place
  • Presence of trans-tricuspid pacemaker or defibrillator leads where: (a)TR is a result of impingement on the tricuspid valve leaflet as evaluated by echocardiography; or (b) implanted in the RV within the last 90 days
  • Primary tricuspid valve disease
  • 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)
  • Currently participating in another investigational biologic, drug, or device study
  • Any of the following cardiovascular procedures:
  • Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
  • Carotid surgery within the last 30 days
  • Direct current cardioversion within the last 30 days
  • Leadless RV pacemaker implant within the last 30 days
  • Cardiac surgery within the last 90 days
  • Any of the following underlying medical conditions:
  • Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
  • Active endocarditis or infection requiring antibiotic therapy (oral or intravenous)
  • Hemodynamically significant pericardial effusion
  • Significant intra-cardiac mass, thrombus, or vegetation
  • Untreated clinically significant coronary artery disease (CAD) requiring revascularization, evidence of acute coronary syndrome, or recent myocardial infarction (MI)
  • Known history of untreated severe symptomatic carotid stenosis (\>50% by ultrasound) or asymptomatic carotid stenosis (\>70% by ultrasound)
  • Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
  • Known bleeding or clotting disorders or patient refuses blood transfusion
  • Active GI bleeding
  • Recent stroke
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months or any planned percutaneous cardiac procedure within the next 90 days
  • Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months
  • Pregnant, breastfeeding, or planning pregnancy within the next 12 months
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator

Key Trial Info

Start Date :

July 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT03382457

Start Date

July 1 2018

End Date

December 31 2031

Last Update

October 9 2025

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Northwestern University

Chicago, Illinois, United States, 60611

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

3

Morristown Medical Center

Morristown, New Jersey, United States, 07962

4

Columbia University Medical Center /New York Presbyterian Hospital

New York, New York, United States, 10032