University Hospital Bern
Bern, 3010, Switzerland
NCT Number: NCT03458988
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. .
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Insel Gruppe AG, University Hospital Bern
Other
Pilot Study to Validate a Novel Blood-pressure Measuring Device in Patients Carrying a Left Ventricular Assist Device
Acronym: LVAD
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.
Published trials that share one or more normalized conditions with this study.
NCT07633535
End-stage Heart Failure, Left Ventricular Assist Device
Antalya, Turkey (Türkiye)
View Trial DetailsNCT01485666
Left Ventricular Assist Device, Percutaneous Lead Management
Birmingham, Alabama, United States
View Trial DetailsNCT01477528
Anticoagulation, Left Ventricular Assist Device
San Diego, California, United States
View Trial DetailsNCT05063006
Cardiovascular Diseases, Heart Diseases
Krakow, Lesser Poland Voivodeship, Poland
View Trial Details