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

March 24, 2026 updated by: Feldman Cardiology, PLLC
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an Early Feasibility Study (EFS) designed to evaluate the performance of the admittance PAC system for measuring RV hemodynamic data, including pressure-volume loops, in patients undergoing clinically indicated tricuspid valve (TV) replacement or clipping. The purpose of the device is to predict RV hemodynamic response prior to TV intervention and to generate preliminary data that may inform design iterations on the admittance PAC prior to device design lockdown.

A total of 8 subjects will be recruited from two clinical sites (4 subjects per site). Participants will be recruited from patients already scheduled to undergo clinically indicated TV intervention.

Data collected using the admittance PAC system will be used to inform design iterations of the invention for research purposes only and will not be shared with interventional cardiologists during the procedure or used to guide clinical decision-making. Standard-of-care right heart catheterization will be performed to obtain clinically required hemodynamic measurements, including right-side pressures and cardiac output. The standard right heart hemodynamics obtained by the admittance PAC will not be used clinically. The research protocol does not alter standard vascular access, sheath size, or procedural workflow beyond the additional data acquisition using the investigational device immediately prior to the interventional TV procedure.

Study Type

Observational

Enrollment (Estimated)

8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtain Ees/Ea consistent with non-invasive literature of TAPSE/PASP: CouplingRatio_ECHO-CouplingRatio_PAC ≤ 0.2 (unitless)
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Feldman Cardiology, PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 10, 2027

Primary Completion (Estimated)

July 10, 2028

Study Completion (Estimated)

July 10, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2026APACS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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