Health TrialsbyHealthPanel

TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

ConditionsTricuspid RegurgitationTricuspid Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorP+F Products + Features USA Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • TricValve® Transcatheter Bicaval Valve System

    Device

    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 system is a single use, sterile device compatible with all the valve sizes. The valves are premounted in the TricValve® Delivery System. 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 available in sizes 25 and 29 for superior vena cava and 31 and 35 for inferior vena cava. The valve is implanted percutaneously by the transfemoral approach. The valves are supplied already premounted into the TricValve® Delivery System.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: TricValve® Device (Device) GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Number of days until death

Time frame
1 Month and 12 Months
2

Stroke

Number of days until death

Time frame
1 Month
3

Pulmonary Embolism

Number of days until death

Time frame
1 Month
4

Valve Academic Research Consortium (VARC) type 2-4 bleeding complication

Number of days until death

Time frame
1 Month

Secondary outcomes

1

Technical success of device placement (at exit from procedure room)

* Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of the device into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

Time frame
Intraprocedural
2

Device success within 30 days after device placement

* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication

Time frame
1 Month
3

Procedural success (at 30 days)

All of the following criteria must be met to be considered a procedural success: * Device success (defined above), and * Absence of major device or procedure related serious adverse events

Time frame
1 Month
4

Mortality

Number of days until death

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

P+F Products + Features USA Inc.

Lead sponsor

P+F Products + Features GmbH

Collaborator

Meditrial USA Inc.

Collaborator

Source ClinicalTrials.gov
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