NCT07500025

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Jul 2027

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 10, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Tricuspid Regurgitation (TR)

Outcome Measures

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.

    1 year

Interventions

Right Heart CatheterizationDEVICE

A right heart catheter is placed in the pulmonary artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start (Estimated)

July 10, 2027

Primary Completion (Estimated)

July 10, 2028

Study Completion (Estimated)

July 10, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share