NCT03458988

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

March 2, 2018

Last Update Submit

November 22, 2021

Conditions

Left Ventricular Assist Device

Keywords

Blood pressure measuring

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

All patients

OTHER

Nellcor™ Adult SpO2 Sensor

Device: Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)

Interventions

Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)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.

Also known as: Nellcor™ Adult SpO2 Sensor
All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 25870369BACKGROUND

  • 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.

    PMID: 24075484BACKGROUND

Study Officials

  • David Reineke, MD

    University Hospial Bern, Cardio Vascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 8, 2018

Study Start

February 27, 2018

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

CH(1)