Severe Tricuspid valve Regurgitation (TR) - severe leaking right heart valve Leaking right heart valve
Conditions
Interventions
T-TEER on top of SOC
The procedure attempts to repair coaptation (edge-to-edge) of the leafletes of 
the tricuspid valve in a minimal invasive manner. All edge-to-edge repair 
systems for TV are allowed in the study, as long as the device has a CE mark 
and has demonstrated safety and efficacy. There are two edge-to-edge T-TEER 
devices available: TriClip (Abbott Vascular) and PASCAL (Edwards Lifesciences). 
Both systems received a CE mark for treating TR in a minimally invasive manner. 
These CE marks are in accordance with the intentional use in the TRACE-NL 
trial.
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patient is symptomatic (NYHA Functional Class II, III or ambulatory class IV) despite Standard Of Care (SOC). The Central Screening Committee (CSC) will assess whether the patient is receiving Standord Of Care (SOC), which for TR is limited to symptomatic treatment with diuretics. The CSC will also ensure that in case of the presence of atrial fibrillation, left sided heart valve disease (not requiring intervention) or coronary artery disease, these conditions are treated adequately with medication and/or intervention/device therapy. 2. The patient suffers from >= grade 3 isolated TR as determined by the assessment of a qualifying TTE and 3DTEE and confirmed by the CSC, according to PCR Tricuspid Focus Group consensus document (in press). Note: If cardiac procedure(s) occur after eligibility was determined, TR grade will be re-assessed 30 days after the procedure. 3. The cardiac surgeon of the sites* local heart team concurs that the patient is at high estimated risk for mortality or morbidity with TV surgery. 4. The patient is >=18 years of age at time of consent. 5. The patient must provide written IC prior to any trial related procedure.
Exclusion criteria
Exclusion criteria: 1. Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by RHC. Severe uncontrolled hypertension Systolic Blood Pressure (SBP) >= 180 mmHg and/or Diastolic Blood Pressure (DBP) >= 110 mmHg. 2. Any condition that would interfere with a TTVr procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude device implantation (e.g. calcification in grasping area, a severe coaptation defect of the tricuspid leaflets (non-clippable), pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of TTVr devices, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of RV), tricuspid valve anatomy non evaluable by echo, known allergy or hypersensitivity to dual antiplatelet therapy AND anticoagulant therapy or to device materials, femoral venous mass or thrombus or vegetation. 3. Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction within prior 60 days. Note: concomitant mitral valve disease (e.g. mitral regurgitation) will be treated first and patients will be reassessed for the trial after 60 days. 4. Tricuspid valve stenosis - Defined as a tricuspid valve orifice of <= 1.0 cm2 and/or mean gradient >=5 mmHg. 5. Left Ventricular Ejection Fraction (LVEF) <=20% 6. Active endocarditis, active rheumatic heart disease, other ongoing infection requiring antibiotic therapy (enrolment possible 30 days after discontinuation of antibiotics with no active infection) or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated) 7. Myocardial infarction known unstable angina, or percutaneous coronary intervention within prior 30 days. 8. Hemodynamic instability defined as systemic systolic pressure <90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or hemodynamic support device (e.g. intra-aortic balloon pump). 9. Cerebrovascular Accident (CVA) within prior 90 days 10. Chronic dialysis 11. Bleeding disorders or hypercoagulable state, inability to use dual antithrombotic therapy due to contraindication, allergy or hypersensitivity 12. Active peptic ulcer or active gastrointestinal (GI) bleeding 13. Life expectancy of less than 12 months 14. Subject currently participating in another clinical trial (not yet completed primary endpoint) or in another clinical investigation for valvular heart disease. 15. Pregnant or nursing patients or those who plan pregnancy during the course of the trial. Women of childbearing age are required to have a negative pregnancy test 7 days prior to baseline visit. Women of childbearing age should be instructed to use safe contraception or have a sterilized regular partner. 16. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the eye of the investigator, limits the subject*s ability to participate in the clinical investigation or comply with follow-up requirements,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as the hierarchical occurrence of all-cause death, hospitalizations related to heart failure, and change in KCCQ at 12 months of follow-up. Death and hospitalization due to heart failure are considered the most significant clinical events that can occur due to TR and are therefore incorporated into the primary endpoint. For the KCCQ-score a 5 point increase is considered as clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoints (assessed at 12 months and at five years of follow-up): - Composite endpoint of all-cause mortality, HFH, change in KCCQ-score - Individual components of the primary outcome: all-cause mortality, HFH, change in KCCQ score - Freedom MAE (30 days and 12 months) - Change in NYHA functional class - Safety endpoints - Success endpoints: procedural success and clinical success - Urgent visit outpatient clinic for heart failure due to (impending) decompensation with symptoms - Change in EQ-5D-5L - TR-reduction from at least severe to moderate or less - Learning curve: procedural parameters (procedure time, number of devices), procedural success (TR reduction), adverse events, clinical outcomes and cost-effectiveness between the frist 8 and last 8 procedures per center. - Cost-effectiveness: Quality Adjusted Life Years (QALY) and Incremental Cost Effectiveness Ratios (ICERs), a formal cost-effectiveness- and budget impact (BIA) analyses will be performed for TTVr. The iMCQ and iPCQ will be used to calculate the in-hospital cost en costs outside the hospital, respectively. Cost-effectiveness and acceptability curves will be made. The BIA comprises the budgetary framework for health care (net-BKZ) perspective and the perspective of the health insurer. - Change in microcirculation | — |
Countries
Netherlands
Contacts
Public ContactMGH Vrijkorte
St. Antonius Ziekenhuis
Outcome results
None listed