Tricuspid Regurgitation (TR)NCT07500025
Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)
An observational study of Tricuspid Regurgitation (TR), run by Feldman Cardiology, PLLC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- Right Heart Catheterization
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2027to 10 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Children (defined as individual <18 years of age) will be excluded from this study
About this study
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.
Read the 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.
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- Right Heart Catheterization
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Heart CatheterizationDevice
A right heart catheter is placed in the pulmonary artery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start10 Jul 2027 (estimated)
- Primary completion10 Jul 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feldman Cardiology, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500025
- Sponsor's protocol ID
- P2026APACS001
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)
- ClinicalTrials.gov ID
- NCT07500025
- Acronym / sponsor ID
- P2026APACS001
- Conditions
- Tricuspid Regurgitation (TR)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Feldman Cardiology, PLLCUniversity, hospital or other
- Study start
- 10 Jul 2027 (estimated)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children (defined as individual <18 years of age) will be excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Heart CatheterizationA right heart catheter is placed in the pulmonary artery | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation (TR), run by Feldman Cardiology, PLLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain Ees/Ea consistent with non-invasive literature of TAPSE/PASP: CouplingRatio_ECHO-CouplingRatio_PAC ≤ 0.2 (unitless) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.