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OpenTrials
Completed

NCT Number: NCT03458988

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

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. .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)

Device

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 names: Nellcor™ Adult SpO2 Sensor

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: LVAD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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