NCT03382457

Brief Summary

Clinical Study of the Edwards Cardioband FIT Repair System

Trial Health

75
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
68mo left

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

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 Progress58%
Jul 2018Dec 2031

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

October 9, 2025

Status Verified

September 1, 2025

Enrollment Period

8.5 years

First QC Date

December 19, 2017

Last Update Submit

October 7, 2025

Conditions

Tricuspid Regurgitation

Keywords

FunctionalTRFTRTranscatheterRepair

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the Edwards Cardioband FIT Repair System

Device: Transcatheter Tricuspid Valve Repair

Interventions

Transcatheter Tricuspid Valve RepairDEVICE

Repair of the tricuspid valve through a transcatheter approach

Also known as: Edwards Cardioband Tricuspid Valve Repair
Treatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Columbia University Medical Center /New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Oregon Health & Science University

Portland, Oregon, 97293, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

  • 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.

    PMID: 33744150DERIVED

  • 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.

    PMID: 33413863DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • William Gray, MD

    Lankenau Heart

    PRINCIPAL INVESTIGATOR

  • Firas Zahr, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

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 19, 2017

First Posted

December 26, 2017

Study Start

July 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Last Updated

October 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(9)