Clinical trial NCT03382457: Clinical Study of Edwards Cardioband FIT Valve Repair System
Official title: Clinical Study of Edwards Cardioband FIT Valve Repair System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Functional
TR
FTR
Transcatheter
Repair
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
timeFrame: 30 days
measure: Primary Performance Endpoint - Intraprocedural Success
timeFrame: Intraprocedural
measure: Primary Performance Endpoint - Clinical Success
timeFrame: 30 days and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center /New York Presbyterian Hospital
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Plano
country: United States
facility: Heart Hospital Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Lankenau Heart
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Firas Zahr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.