Symptomatic Severe Tricuspid Regurgitation
Conditions
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.
Interventions
DEVICETriFlo Tricuspid Flow Optimizer
An introducer sheath is inserted into the femoral vein over a stiff guidewire; the sheath extends into the common iliac vein and inferior vena cava and in the right atrium. The TFO device is oriented coaxiality to the tricuspid. Once released, the delivery catheter and the steerable catheter are removed the access site closure performed by a cardiovascular or vascular surgeon or with pre-implanted percutaneous sutures per site preference.
Sponsors
TriFlo Cardiovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective single-arm, multicenter pre-market study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Symptomatic severe tricuspid regurgitation 3+ on a scale of 0+ to 5+, according to semi-quantitative echocardiographic color flow doppler evaluation 3. Tricuspid valve (TV) morphology which fulfills anatomic criteria of eligibility for the device according to Imaging Core Lab assessment 4. Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related procedure 5. Available and able to return to the study site for post-procedural follow-up examination
Exclusion criteria
CARDIOVASCULAR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE) | 30 days | a composite of death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TFO implantation, bleeding). |
Countries
Italy
Contacts
Primary ContactMonica Tocchi, MD
Outcome results
None listed