Blood-pressure Measuring in Patients Carrying a Left Ventricular Assist Device

Study Overview
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Brief Summary
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To prove the novel device is able to reliably detect pulsatility in patients with CF-VADs and to analyze whether pre-programmed intrinsic pulsatility of the 3rd generation CF-VADs can also be picked up. The study is not designed to measure blood pressure. Should this pilot study be successful in detecting enough pulsatility a follow-up study would then try to transfer the results into blood-pressure values with the help of comparators in order to identify an easier and more reliable method to measure BP in CF-VAD patients. .

Detailed Description
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The number of patients supported by left ventricular assist device (LVAD) is increasing as durable mechanical support has become widely available for end stage heart failure as destination therapy and as bridge to transplantation. The accurate measurement of blood pressure (BP) as well as the recognition and management of hypertension in patients with LVADs is an essential component of optimal clinical care. Hypertension is an established long-term risk factor for cardiovascular disease. The measurement of BP and the management of hypertension in patients with CF-VADs can present unique challenges. Patients with LVADs often do not have a palpable pulse, and therefore traditional BP measurement by auscultation or automated cuff is less reliable. Conventional occlusive BP measurement is able to to pick up signals in approximately 50% of cases due to coincidental phases of pulsatility. The arterial line is the gold standard, but is an invasive procedure and not practical for routine outpatient use. Although efforts are underway to identify an easier and more reliable method to measure ambulatory BP in these patients not one has been able to match the quality of an invasive arterial line.

Official Title
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Pilot Study to Validate a Novel Blood-pressure Measuring Device in Patients Carrying a Left Ventricular Assist Device

Conditions
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Left Ventricular Assist Device

Intervention / Treatment
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* Device: Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients carrying one of the two third generation CF-VADS (Heartware HVAD, Heartmate 3) Patients >18y Good understanding of written and oral German Signed informed consent Scheduled for routine outpatient appointment. Exclusion Criteria: In the population of the outpatient clinic's CV-LVAD patients no known exclusion criteria exists

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>Nellcor™ Adult SpO2 Sensor | Device: Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)<br>* Data will be acquired for 10 minutes with a reusable off the shelf adult SpO2 sensor. The Nellcor™ Adult SpO2 Sensor, model DS-100A, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 40 kg.<br>* Other names: Nellcor™ Adult SpO2 Sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR (Riva Rocci, indirect blood pressure measurement) in LVAD | Detect pulsatility in CF-VAD (Continuous flow- ventricular assist device) patients sufficient to calculate comprehensible blood-pressure values in future follow-up studies | 10 min blood measuring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure measuring