NL-OMON53966
Not yet recruiting
Not Applicable
Evaluation of the safety, efficacy and cost-effectiveness of transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation in the Netherlands. - TRACE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Tricuspid valve Regurgitation (TR) - severe leaking right heart valve
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 150
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
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
Outcomes
Primary Outcomes
Not specified
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