NCT03493074

Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)

Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

Detailed description

Abdominal aortic aneurysm (AAA) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. In 50% of cases, AAA rupture may lead to death and 50% of the remaining patients referred to hospital die. This results in high costs and preventable loss of lives. AAA can also be detected by pulse wave (PW) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of AAAs. The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (PPG) PWs and dynamic blood pressure PWs). The objective is to study PWs in the detection of AAA and the effects of endovascular repair (EVAR) and whether adverse effects (i.e. endograft failure) can be detected. It is hypothesized that AAA and failure of the operation can be detected by PW features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. It could also enable patient-centered, comfort follow-up for patients treated by EVAR.

Conditions

• Cardiovascular Diseases
• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Noninvasive pulse wave analysis sensor, ECG-sensor	The sensors are noninvasively attached

Timeline

• Start date: 2018-04-08
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2018-04-10
• Last updated: 2020-10-09

Locations

1 site across 1 country: Finland