Categorizing Patient Risk for Tricuspid Regurgitation (TR... | NCT07500025

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

NCT07500025

Sponsor

Feldman Cardiology, PLLC

Status

Not yet recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

8Estimated

Phase

Not provided

Conditions

Tricuspid Regurgitation (TR)

Interventions

Right Heart Catheterization

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2027Estimated

Primary Completion Date

Jul 10, 2028Estimated

Completion Date

Jul 10, 2028Estimated

First Submitted Date

Mar 24, 2026

First Submission Date that Met QC Criteria

Mar 24, 2026

First Posted Date

Mar 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Right Heart Catheterization	Device	A right heart catheter is placed in the pulmonary artery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided