Brachial Right Ventricle - Endomyocardial Biopsy

A Novel Method for Cardiac Allograft Monitoring:Transbrachial Right Ventricle Endomyocardial Biopsy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05289180

Enrollment

Registered

2022-03-21

Start date

2022-10-24

Completion date

2023-12-08

Last updated

2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Brief summary

This is an observational study that will recruit NYU Langone patients undergoing standard of care right ventricle endomyocardial biopsy. Patients who undergo planned RV-EMB via transbrachial access will be invited to take part in the study.

Detailed description

Data including severity of tricuspid regurgitation and tamponade from pre and post procedure bedside echocardiograms, total procedure duration, radiation exposure and fluoroscopy time, sedatives used (if any) and bleeding/hematoma formation (if any) will be collected. A post-procedural survey will be administered to patients by study staff to assess comfort level and anxiety during procedure. A post procedure phone call will take place 3-5 days after procedure to assess for bruising, swelling or bleeding at the site of Brachial RV-EMB.

Interventions

OTHERQuestionnaires

A questionnaire will be administered post-procedure to assess for pain and anxiety. This questionnaire will be administered by study personnel delegated to administer questionnaires, namely the study coordinator or PI.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patient is 18 to 90 years old * Patient is undergoing standard of care right heart catheterization with endomyocardial biopsy * Patient has right arm brachial access available * Patient is willing and able to provide written informed consent.

Exclusion criteria

* Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula * Severe untreated tricuspid valve regurgitation * Female patients who are pregnant

Design outcomes

Primary

Measure	Time frame	Description
Patient Satisfaction in Right endomyocardial biopsy via brachial access	Day 1 to Day 540	Assessed by patients self report of their experience when undergoing right endomyocardial biopsy via brachial access compared to transjugular and transfemoral right ventricle endomyocardial biopsy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026