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OpenTrials
Completed

NCT Number: NCT05289180

Brachial Right Ventricle - Endomyocardial Biopsy

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.

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Key information

Conditions

Heart Transplantation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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.

Primary outcomes

  1. Patient Satisfaction in Right endomyocardial biopsy via brachial access

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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