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Due to COVID and staffing issues study was terminated
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The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Resynchronization Therapy (CRT) Group | Active Comparator | Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue |
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| Control Group | Active Comparator | Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous adipose tissue collection | Procedure | During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vascular endothelial function | Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months. | baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hon-Chi Lee, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Peripheral arterial tonometry (PAT) | Diagnostic Test | Non-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI) |
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