NCT07224906

Brief Summary

The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

October 31, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

October 31, 2025

Last Update Submit

April 9, 2026

Conditions

Pulmonary HypertensionCongestive Heart Failure(CHF)Valve Disease, Heart

Outcome Measures

Primary Outcomes (1)

  • Association between device measurements and Pulmonary Capillary Wedge Pressure

    The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects above the age of 18 who meet all inclusion/exclusion criteria.

You may qualify if:

  • Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
  • Subjects can be any gender but must be age 18 or older.
  • Subject is able and willing to provide informed consent and HIPAA authorization.
  • Subject is able and willing to meet all study requirements.
  • Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible)

You may not qualify if:

  • Subject is pregnant, breastfeeding, or intends to become pregnant during this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boulder Heart

Boulder, Colorado, 80303, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryHeart FailureHeart Valve Diseases

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart Diseases

Central Study Contacts

Katharine Adkins

CONTACT

303-442-2395kathari.adkins@bch.org

Study Design

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

Study Record Dates

First Submitted

October 31, 2025

First Posted

November 5, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)