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

Left Ventricular Assist Device Clinical Trial

— LVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458988
• Other study ID #: 2017-01570
• Status: Completed
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Assist Device

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Lampert BC, Eckert C, Weaver S, Scanlon A, Lockard K, Allen C, Kunz N, Bermudez C, Bhama JK, Shullo MA, Kormos RL, Dew MA, Teuteberg JJ. Blood pressure control in continuous flow left ventricular assist devices: efficacy and impact on adverse events. Ann Thorac Surg. 2014 Jan;97(1):139-46. doi: 10.1016/j.athoracsur.2013.07.069. Epub 2013 Sep 25. — View Citation

Saeed O, Jermyn R, Kargoli F, Madan S, Mannem S, Gunda S, Nucci C, Farooqui S, Hassan S, Mclarty A, Bloom M, Zolty R, Shin J, D'Alessandro D, Goldstein DJ, Patel SR. Blood pressure and adverse events during continuous flow left ventricular assist device support. Circ Heart Fail. 2015 May;8(3):551-6. doi: 10.1161/CIRCHEARTFAILURE.114.002000. Epub 2015 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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