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

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ClinicalTrials.gov Identifier: NCT03458988
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

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. .


Condition or disease Intervention/treatment Phase
Left Ventricular Assist Device Device: Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Validate a Novel Blood-pressure Measuring Device in Patients Carrying a Left Ventricular Assist Device
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : February 28, 2020

Arm Intervention/treatment
All patients
Nellcor™ Adult SpO2 Sensor
Device: Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)
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.
Other Name: Nellcor™ Adult SpO2 Sensor




Primary Outcome Measures :
  1. RR (Riva Rocci, indirect blood pressure measurement) in LVAD [ Time Frame: 10 min blood measuring ]
    Detect pulsatility in CF-VAD (Continuous flow- ventricular assist device) patients sufficient to calculate comprehensible blood-pressure values in future follow-up studies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458988


Contacts
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Contact: David Reineke, MD +41-31-6322376 david.reineke@insel.ch
Contact: Dorothee Keller +41-31-6323606 dorothee.keller@insel.ch

Locations
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Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: David Reineke, MD    +41-31-6322376    david.reineke@insel.ch   
Contact: Dorothee Keller    +41-316323606    dorothee.keller@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: David Reineke, MD University Hospial Bern, Cardio Vascular Surgery