A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- P+F Products + Features USA Inc.
- Enrollment
- 50
- Locations
- 36
- Primary Endpoint
- Mortality
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
Detailed Description
This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery. Patients who meet all of the study inclusion criteria, will be treated with the TricValve System. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must be 18 years or older, at the time of signing the informed consent.
- •Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
- •NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
- •Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.
- •The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
- •For females of childbearing potential, negative pregnancy test.
- •Capable of giving signed informed consent.
Exclusion Criteria
- •Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.
- •Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).
- •LVEF ≤ 30% on echocardiography.
- •Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- •Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 \[at least 0.75 if BMI \>30 kg/m2\], DVI \<2.2, mean gradient \<5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild \[1+\]) or acceptable (≤ moderate \[2+\]).
- •Severe right ventricular dysfunction.
- •Cardiac amyloidosis
- •Pulmonary artery systolic pressure (PASP) \>65 mmHg assessed with Echo Doppler and /or right heart catheterization.
- •Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
- •Hemodynamically significant pericardial effusion.
Outcomes
Primary Outcomes
Mortality
Time Frame: 1 Month and 12 Months
Number of days until death
Stroke
Time Frame: 1 Month
Number of days until death
Pulmonary Embolism
Time Frame: 1 Month
Number of days until death
Valve Academic Research Consortium (VARC) type 2-4 bleeding complication
Time Frame: 1 Month
Number of days until death
Major vascular, access-related, or cardiac structural complication
Time Frame: 1 Month
Number of days until death
Emergency surgery or intervention related to the device/procedure complications
Time Frame: 1 Month
Number of days until emergency surgery or intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Time Frame: 12 Months
Change in KCC score (score ranges between 0 and 100)
Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ≥4.0mg/dL (≥354 μmol/L) with an acute increase of ≥ 0.5 mg/dL (≥44 μmol/L)
Time Frame: 7 Days
Number of days from baseline until increase
Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy
Time Frame: 1 Month
Number of days until new renal replacement therapy
Right Ventricular Assist Device (RVAD) implantation or heart transplant
Time Frame: 12 Months
Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
Tricuspid valve surgery or percutaneous tricuspid intervention
Time Frame: 12 Months
Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
Heart Failure Events
Time Frame: 12 Months
Number of heart failure episodes including hospitalization, or worsening heart failure
New York Heart Association (NYHA class)
Time Frame: 12 Months
Change in NYHA class (range from I to IV)
Six Minute Walking Test (6MWT)
Time Frame: 12 Months
Change in walking distance
Secondary Outcomes
- Six Minute Walking Test (6MWT)(12 Months)
- Tricuspid valve surgery or percutaneous tricuspid intervention(12 Months)
- New York Heart Association (NYHA class)(12 Months)
- Technical success of device placement (at exit from procedure room)(Intraprocedural)
- Device success within 30 days after device placement(1 Month)
- Heart Failure hospitalization or worsening Heart Failure (HF) which encompasses treatment with IV diuretics in the office or Emergency Department treatment during a <24-hour time period(12 Months)
- Mortality(12 Months)
- RVAD implantation or heart transplant(12 Months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Score(12 Months)
- Procedural success (at 30 days)(1 Month)