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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05289180
Other study ID # 21-01132
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 24, 2022
Est. completion date December 8, 2023

Study information

Verified date April 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date December 8, 2023
Est. primary completion date December 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
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.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction in Right endomyocardial biopsy via brachial access 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. Day 1 to Day 540
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