ACTIVE_NOT_RECRUITING

Clinical Study of Edwards Cardioband FIT Valve Repair System

Conditions

Tricuspid Regurgitation Functional TR FTR Transcatheter Repair

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Clinical Study of the Edwards Cardioband FIT Repair System

Official Title

Clinical Study of Edwards Cardioband FIT Valve Repair System

Quick Facts

Study Start:2018-07-01

Study Completion:2031-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03382457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * 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 * 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

Inclusion Criteria

Exclusion 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

* 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
* 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
* 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

Contacts and Locations

Principal Investigator

William Gray, MD

PRINCIPAL_INVESTIGATOR

Lankenau Heart

Firas Zahr, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Morristown Medical Center

Morristown, New Jersey, 07962

United States

Columbia University Medical Center /New York Presbyterian Hospital

New York, New York, 10032

United States

Oregon Health & Science University

Portland, Oregon, 97293

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

Heart Hospital Baylor Plano

Plano, Texas, 75093

United States

Intermountain Medical Center

Murray, Utah, 84107

United States

University of Virginia Health System

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

William Gray, MD, PRINCIPAL_INVESTIGATOR, Lankenau Heart
Firas Zahr, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-01

Study Completion Date2031-12-31

Study Record Updates

Study Start Date2018-07-01

Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

Functional
TR
FTR
Transcatheter
Repair

Additional Relevant MeSH Terms

Tricuspid Regurgitation