Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- Xijing Hospital
- Enrollment
- 5
- Primary Endpoint
- Severe adverse device events (SADE)
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.
Detailed Description
This study is a prospective single-arm trial for transcatheter tricuspid valve repair system (Trialign). A series of physical, imaging and laboratory exams will be performed to determine whether a subject has moderate to severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receiveTrialign treatment if an informed consent is obtained.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects has been informed the study and provided written informed consent.
- •Age ≥ 18 and ≤ 85 years old.
- •NYHA class II, III or ambulatory IV.
- •The subject was diagnosed moderate to severe functional tricuspid regurgitation
- •The subject was at high risk for open heart valve surgery. The heart team recommended tricuspid annuloplasty.
- •Subjects shall meet all selected criteria for TEE with moderate or severe tricuspid regurgitation.
- •Systolic pulmonary artery pressure (SPAP) ≤ 60mmHg.
- •Left ventricular ejection fraction (LVEF) ≥ 30%.
- •Right ventricle tricuspid annular plane systolic excursion (TAPSE) ≥ 15 mm.
- •Tricuspid valve annular diameter ≤ 55 mm.
Exclusion Criteria
- •Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg).
- •History of heart transplant.
- •Previous tricuspid valve repair or replacement (including artificial valve).
- •Presence of a left ventricular assist device.
- •Active endocarditis.
- •Severe degenerative tricuspid valve disease.
- •Severe aortic stenosis.
- •The degree of mitral regurgitation is greater than grade
- •Complete occlusion due to chronic calcification of the right coronary artery.
- •History of right internal jugular vein occlusion or thrombosis;
Outcomes
Primary Outcomes
Severe adverse device events (SADE)
Time Frame: 30 days
Severe adverse device events (SADE) , defined as any device related complication, including but not limited to: death, myocardial infarction, stroke, reoperation, renal failure, pulmonary embolism, gastrointestinal bleeding, readmission, etc.
Secondary Outcomes
- 6-minute walk test (6MWT)(6 months)
- Technical success(30 days)
- New York Heart Association (NYHA) classification(6 months)
- EuroQol five dimensions questionnaire (EQ-5D)(6 months)
- Evaluation of tricuspid valve function(6 months)
- Incidence of adverse events(6 months)