Transcatheter Treatment of Tricuspid Valve Regurgitation With the TriFlo Tricuspid Flow Optimizer (TFO) System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Symptomatic Severe Tricuspid Regurgitation
- Sponsor
- TriFlo Cardiovascular, Inc.
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Tricuspid Regurgitation induces an asymmetric enlargement of the tricuspid valve (TV) annulus causing a reduction of leaflets coaptation. Annular dilation continues even after surgical treatment. The progressive nature of TR, inadequate surgical treatment, and high-risk patient population make TR an ideal target for transcatheter therapy. The TriFlo TFO System introduces a new concept for the treatment of tricuspid regurgitation. Its commissural anchoring is designed to respect TV leaflet integrity, mobility, and maintain RV contractility.
Detailed Description
This study is a prospective single-arm, multicenter pre-market study. Recent epidemiological data estimate the prevalence of significant tricuspid regurgitation (TR) in the general population to be as high as 0.55% (and up to 3% after 75 years of age), a prevalence comparable to aortic stenosis (AS) or mitral regurgitation (MR). Although the prevalence is high, TR is often not treated. In the United States, approximately 1.6 million patients live with moderate to severe TR, and fewer than 8,000 tricuspid surgeries are performed annually. Clinically relevant TR is present in approximately 3.0 million individuals in Europe and 70 million people worldwide. Approximately 90% of TR in adults is functional (secondary) and can be due to left-sided myocardial or valvular disease, pulmonary vascular disease, right ventricular myopathy,chronic right ventricular volume overload, or idiopathic. Uncertainty about the impact of TR on outcomes is related to the heterogeneous nature of the tricuspid disease, which is often secondary to other conditions (mainly left-sided disease or pulmonary hypertension). In spite of its high prevalence, tricuspid valve disease is a largely untreated condition and is known to be associated with poor life expectancy. The purpose of this clinical study is to evaluate the safety and clinical efficacy of the TriFlo Tricuspid Flow Optimizer in the treatment of severe TR.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Symptomatic severe tricuspid regurgitation 3+ on a scale of 0+ to 5+, according to semi-quantitative echocardiographic color flow doppler evaluation
- •Tricuspid valve (TV) morphology which fulfills anatomic criteria of eligibility for the device according to Imaging Core Lab assessment
- •Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related procedure
- •Available and able to return to the study site for post-procedural follow-up examination
Exclusion Criteria
- •CARDIOVASCULAR EXCLUSION CRITERIA
- •Requirement for an interventional percutaneous procedure or cardiac surgical procedure \<30 days before or after index procedure
- •Prior tricuspid repair or replacement, implantation of an artificial heart valve.
- •Active endocarditis or history of endocarditis within the previous 12 months.
- •Left Ventricular Ejection Fraction \<30%
- •Severe aortic and mitral stenosis and/or regurgitation
- •Severe tricuspid valve stenosis
- •Severe right ventricular failure
- •Systolic Pulmonary Artery pressure \>70 mmHg
- •Echocardiographic evidence of intracardiac mass, thrombus, tumor, myxoma or vegetation
Outcomes
Primary Outcomes
Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
Time Frame: 30 days
a composite of death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TFO implantation, bleeding).