Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Right Heart Catheterization.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation (TR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Device Right Heart Catheterization
A right heart catheter is placed in the pulmonary artery
Primary outcome measures
- Obtain Ees/Ea consistent with non-invasive literature of TAPSE/PASP: CouplingRatio_ECHO-CouplingRatio_PAC ≤ 0.2 (unitless) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07500025 · P2026APACS001