Blood-pressure Measuring in Patients Carrying a Left Ventricular Assist Device (LVAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03458988|
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : January 16, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
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
|Contact: David Reineke, MDfirstname.lastname@example.org|
|Contact: Dorothee Kelleremail@example.com|
|University Hospital Bern||Recruiting|
|Bern, Switzerland, 3010|
|Contact: David Reineke, MD +41-31-6322376 firstname.lastname@example.org|
|Contact: Dorothee Keller +41-316323606 email@example.com|
|Principal Investigator:||David Reineke, MD||University Hospial Bern, Cardio Vascular Surgery|