Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFeldman Cardiology, PLLC

About this trial

The study is focused on evaluation of the effectiveness of the Admittance Pulmonary Artery Catheter (PAC) system for assessing the right ventricular (RV) function in patients with tricuspid regurgitation (TR) prior to tricuspid valve intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with severe or torrential TR who are already scheduled to undergo clinically indicated tricuspid valve (TV) percutaneous replacement or clipping to reduce heart failure symptoms

Disqualifiers

Children (defined as individual <18 years of age) will be excluded from this study

Trial population

Patients with severe or torrential TR who are already scheduled to undergo clinically indicated tricuspid valve (TV) percutaneous replacement or clipping to reduce heart failure symptoms

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Right Heart Catheterization

    Device

    A right heart catheter is placed in the pulmonary artery

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Obtain Ees/Ea consistent with non-invasive literature of TAPSE/PASP: CouplingRatio_ECHO-CouplingRatio_PAC ≤ 0.2 (unitless)

We will obtain end-systolic elastance (Ees), arterial elastance (Ea) and its ratio (Ees/Ea) derived from pressure-volume loops. Ees represents RV strength of contraction, Ea represents RV afterload from the pulmonary circuit.

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: