Clinical Study of Edwards Cardioband FIT Valve Repair System

Clinical Study of the Edwards Cardioband FIT Repair System

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Repair

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

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center /New York Presbyterian Hospital
  • Oregon
    • Portland, Oregon, United States, 97293
      • Oregon Health & Science University
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Texas
    • Plano, Texas, United States, 75093
      • Heart Hospital Baylor Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment with the Edwards Cardioband FIT Repair System	Device: Transcatheter Tricuspid Valve Repair; Repair of the tricuspid valve through a transcatheter approach; Other Names: Edwards Cardioband Tricuspid Valve Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate	Number and percentage of patients who experienced at least one major adverse event (MAE).	30 days
Primary Performance Endpoint - Intraprocedural Success	Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.	Intraprocedural
Primary Performance Endpoint - Clinical Success	Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.	30 days and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Number and percentage of patients who had Device Success, definition modified from MVARC criteria. Per device analysis.	Intraprocedural
Procedural Success	Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis.	Discharge (2-7 days)
Clinical Success	Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis.	30 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: William Gray, MD, Lankenau Heart; Principal Investigator: Firas Zahr, MD, Oregon Health and Science University

Publications and helpful links

General Publications

• Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available.
• Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Functional; Transcatheter; Repair; FTR; TR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2017-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes