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Observational study to compare Non-Invasive Venous waveform Analysis (NIVA) with Pulmonary Capillary Wedge Pressure (PCWP) during right heart catheterization

Recruiting

NIVA measurements will be obtained concurrently with pulmonary catheter wedge pressures during right heart catheterization.

I'm interested

18 Years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, greater than or equal to 18 years of age
Exclusion Criteria:
Right Heart Catheterization Study Arm & Summative Arm: An individual who meets any of the following criteria will be excluded from participation or data analysis (if found post-hoc around time of RHC) in this study:
• Severe cardiac valvular disease of any cardiac valve, moderate tricuspid disease both regurgitation and stenosis
• Clinical diagnosis of restrictive cardiomyopathy or amyloidosis
• Clinical diagnosis of constrictive pericarditis/cardiac tamponade
• Receiving intravenous: nitrosovasodialtors, epoprostenol, milrinone, dobutamine, dopamine, norepinephrine, phenylephrine, and/or epinephrine.
• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)
• Repaired/Unrepaired Cyanotic Heart Disease, Unrepaired septal defect, Obstructive right heart valvular lesions
• Carries the diagnosis of superior vena cava (SVC) syndrome
• Active and/or history of upper extremity Deep Vein Thrombosis (DVT)
• Previous Arterial-Venous Fistula or Graft on NIVA measurement arm
• Active infection or sepsis
• Pregnant or lactating
• Known psychiatric or neurologic disease or prisoners who are unable to consent
• Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating. SARS-CoV2 Study Arm: An individual who meets any of the following criteria will be excluded from participation in this study:
• Severe cardiac valvular disease of any cardiac valve, moderate tricuspid disease both regurgitation and stenosis
• Clinical diagnosis of restrictive cardiomyopathy or amyloidosis
• Clinical diagnosis of constrictive pericarditis/cardiac tamponade
• Receiving intravenous: nitrosovasodialtors, epoprostenol, milrinone, dobutamine, dopamine, norepinephrine, phenylephrine, and/or epinephrine.
• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)
• Repaired/Unrepaired Cyanotic Heart Disease, Unrepaired septal defect, Obstructive right heart valvular lesions
• Superior vena cava (SVC) syndrome
• Active and/or history of upper extremity Deep Vein Thrombosis (DVT)
• Previous Arterial-Venous Fistula or Graft on NIVA measurement arm
• Active infection or sepsis
• Known psychiatric or neurologic disease or prisoners who are unable to consent
• Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating.

Diabetes & Endocrine

Clinics and Surgery Center (CSC), NIVA Right Heart Catheterization Study

Mary Farnsworth - ewigx005@umn.edu
Eric Wise
NA
STUDY000014969
SURG-2021-30253

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