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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing Heart Catherization | Participants undergoing Heart Catherization and will complete a research survey focusing on the comfort and anxiety during procedure. Participants will be followed for 18 months after enrollment. For each clinically indicated Brachial RV-EMB Biopsy during the 18-month follow up period, data from biopsy and pre and post-procedure echocardiograms will be reviewed and recorded for research purposes. A post-procedure questionnaire and post-discharge phone call will also take place after each procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Right heart endomyocardial biopsy is classically approached via jugular or femoral access. Brachial access has not been widely studied and appears to be an efficient and safe method for performing endomyocardial biopsies. We hypothesize that transbrachial right endomyocardial biopsy is a safe, comfortable and equally effective procedure to endomyocardial biopsies via classical access methods. This single arm study will focus on brachial endomyocardial biopsy and will be compared with historical data.
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| Name | Affiliation | Role |
|---|---|---|
| Tajinderpal Saraon | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
De-identified participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Tajinderpal.Saraon@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |