TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) (NCT06137807) | Clinical Trial Compass
RecruitingNot Applicable
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
United States50 participantsStarted 2024-07-23
Plain-language summary
The TricValveĀ® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValveĀ® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValveĀ® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValveĀ® Transcatheter Bicaval Valves are pre-mounted into the TricValveĀ® Delivery System which is used for percutaneous access and delivery of the TricValveĀ® 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Subject must be 18 years or older, at the time of signing the informed consent.
ā. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
ā. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
ā. 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.
ā. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
ā. For females of childbearing potential, negative pregnancy test.
ā. Capable of giving signed informed consent.
Exclusion criteria
ā. 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.
What they're measuring
1
Mortality
Timeframe: 1 Month and 12 Months
2
Stroke
Timeframe: 1 Month
3
Pulmonary Embolism
Timeframe: 1 Month
4
Valve Academic Research Consortium (VARC) type 2-4 bleeding complication
Timeframe: 1 Month
5
Major vascular, access-related, or cardiac structural complication
Timeframe: 1 Month
6
Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ā„4.0mg/dL (ā„354 Ī¼mol/L) with an acute increase of ā„ 0.5 mg/dL (ā„44 Ī¼mol/L)
Timeframe: 7 Days
7
Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy
Timeframe: 1 Month
8
Emergency surgery or intervention related to the device/procedure complications
ā. 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.).
ā. LVEF ā¤ 30% on echocardiography.
ā. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
ā. 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 (ā¤ mild \[1+\]) or acceptable (ā¤ moderate \[2+\]).
ā. Severe right ventricular dysfunction.
ā. Cardiac amyloidosis
ā. Pulmonary artery systolic pressure (PASP) \>65 mmHg assessed with Echo Doppler and /or right heart catheterization.
9
Right Ventricular Assist Device (RVAD) implantation or heart transplant
Timeframe: 12 Months
10
Tricuspid valve surgery or percutaneous tricuspid intervention
Timeframe: 12 Months
11
Heart Failure Events
Timeframe: 12 Months
12
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score