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

NCT ID: NCT03458988

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-27

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Left Ventricular Assist Device

Keywords

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Blood pressure measuring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patients

Nellcor™ Adult SpO2 Sensor

Group Type OTHER

Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Nellcor™ Adult SpO2 Sensor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Reineke, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospial Bern, Cardio Vascular Surgery

Locations

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University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 25870369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24075484 (View on PubMed)

Other Identifiers

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2017-01570

Identifier Type: -

Identifier Source: org_study_id