Eligibility Details:
Inclusion Criteria:
- In the judgment of the sites local heart team, subject has been adequately treated per
applicable standards (including medical management) and stable for at least 30 days as
follows:
- Optimized medical therapy for treatment of TR (e.g. diuretics).
- Medical and/or device therapy, for mitral regurgitation, atrial fibrillation,
coronary artery disease and heart failure.
- The Eligibility Committee will confirm that the subject has been adequately
treated medically.
- Subject is symptomatic with Severe TR despite being optimally treated as described
above. TR severity is determined by the assessment of a qualifying TTE and confirmed
by the ECL. The ECL may request a TEE to confirm TR etiology. Note: If any cardiac
procedure(s) occur after eligibility was determined, TR severity will need to be
re-assessed 30 days after the cardiac procedure(s).
- The cardiac surgeon of the Site Heart Team concur that the patient is at intermediate
or greater estimated risk of mortality with tricuspid valve surgery.
- New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
- In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is
determined to be feasible and can accommodate a 25 Fr catheter.
- Age ≥18 years at time of consent.
- Subject must provide written informed consent prior to any trial related procedure.
Exclusion Criteria:
- Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary
hypertension as assessed by right heart catheterization (RHC)
- Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or
Diastolic Blood Pressure (DBP) ≥ 110 mm Hg)
- Any prior tricuspid valve procedure that would interfere with placement of the
TriClip(TM) device
- Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation)
or pulmonary valve correction prior 60 days). Note: Patients with concomitant Mitral
and tricuspid valve disease will have the option of getting their MR treated, and wait
60 days prior to being reassessed for the trial.
- Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM)
device.
- Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or
mean gradient ≥5 mmHg as measured by the ECL
- Left Ventricular Ejection Fraction (LVEF) ≤20%
- Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip
positioning on the leaflets or sufficient reduction in TR. This may include:
- Evidence of calcification in the grasping area
- Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets
- Severe leaflet defect(s) preventing proper device placement
- Ebstein Anomaly - Identified by having a normal annulus position while the valve
leaflets are attached to the walls and septum of the right ventricle.
- Tricuspid valve anatomy not evaluable by TTE and TEE
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from
rheumatic disease (i.e. noncompliant, perforated).
- MI or known unstable angina within prior 30 days
- Percutaneous coronary intervention within prior 30 days
- Hemodynamic instability defined as systolic pressure < 90 mmHg with or without
afterload reduction, cardiogenic shock or the need for inotropic support or
intra-aortic balloon pump or other hemodynamic support device.
- Cerebrovascular Accident (CVA) within prior 90 days
- Chronic dialysis
- Bleeding disorders or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (GI) bleeding
- Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant
therapy.
- Note: Contraindication to either antiplatelet or anticoagulant therapy
(individually not both therapies) is not an exclusion criterion.
- Ongoing infection requiring current antibiotic therapy (if temporary illness, patients
may enroll 30 days after discontinuation of antibiotics with no active infection).
- Known allergy or hypersensitivity to device materials
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus
or vegetation.
- Life expectancy of less than 12 months
- Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint.
- Subject is currently participating in another clinical investigation for valvular
heart disease(s).
- Pregnant or nursing subjects and those who plan pregnancy during the clinical
investigation follow-up period. Female subjects of child-bearing potential are
required to have a negative pregnancy test done within 7 days of the baseline visit
per site standard test. Female patients of childbearing potential should be instructed
to use safe contraception (e.g., intrauterine devices, hormonal contraceptives:
contraceptive pills, implants, transdermal patches hormonal vaginal devices,
injections with prolonged release.) It is accepted, in certain cases, to include
subjects having a sterilized regular partner or subjects using a double barrier
contraceptive method.
- Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.
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