Evaluation of the safety, efficacy and cost-effectiveness of transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation in the Netherlands.

• Conditions: Severe Tricuspid valve Regurgitation (TR) - severe leaking right heart valve; 10046973

• Registration Number: NL-OMON53966
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 150

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

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, or impact the scientific soundness of the investigation
results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified