Left Ventricular Assist Device Clinical Trial
— LVADOfficial title:
Pilot Study to Validate a Novel Blood-pressure Measuring Device in Patients Carrying a Left Ventricular Assist Device
Verified date | November 2021 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. .
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
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
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 |
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