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

Not Applicable

Completed

• Conditions: Left Ventricular Assist Device
• Interventions: Device: Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)

• Registration Number: NCT03458988
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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. .

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.

Study Timeline

• Study Start: 2018-02-27
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)	Nellcor™ Adult SpO2 Sensor

Primary Outcome Measures

Name	Time	Method
RR (Riva Rocci, indirect blood pressure measurement) in LVAD	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

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland