Health TrialsbyHealthPanel

TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System

ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCardiovalve Ltd.

About this trial

This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥ 18 and <85 years

Severe tricuspid regurgitation (TR) ≥3+ based upon echocardiography, as assessed by independent core laboratory using a 5-grade classification (mild (1), moderate (2), severe (3), massive (4), torrential (5)). Trace and no TR is considered 0)29

Symptomatic, NYHA Class II-IV

Left ventricular ejection fraction (LVEF) ≥ 30%

Disqualifiers

Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT)

Venous peripheral anatomy or any spinal anatomy that is unsuitable for Cardiovalve TR implant delivery (by CT)

Primary tricuspid disease that may interfere with Cardiovalve implantation

Severe right ventricular failure (by Echo core lab adjudication)

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardiovalve TR valve replacement System

    Device

    Cardiovalve Tricuspid Valve Replacement system

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Cardiovalve TR valve replacement SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from device or procedure-related adverse events

Freedom from device or procedure-related adverse events

Time frame
30 days
2

Reduction in TR grade

Reduction in TR in comparison to baseline

Time frame
30 days

Secondary outcomes

1

Six minute walk test

Change in Six minute walk distance from Baseline

Time frame
30 days, 6 months, 12 months, annual for five years
2

KCCQ

Change in health status from Baseline

Time frame
30 days, 6 months, 12 months, annual for five years

Other outcomes

Sponsors and contacts

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

Cardiovalve Ltd.

Lead sponsor

Source ClinicalTrials.gov
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