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

Cardiovascular Diseases Clinical Trial

— VBA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03493074
• Other study ID #: R17129
• Status: Recruiting
• Start date: April 8, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2020
• Source: Tampere University Hospital
• Contact: Niku Oksala, Professor
• Phone: 400591911
• Email: niku.oksala[@]professori.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• The patient has been clinically examined at policlinic of vascular surgery

• The patient has been examined with computed tomography (CT) imaging

• The patient has been considered a candidate for the EVAR of the AAA

Exclusion Criteria:

• A patient has a pacemaker

• A medical doctor decides that the measurement disturbs or risks the subject's treatment process

• Subject's denial (or withdrawal)

• A patient has at least one amputated limb

• The age of the test subject candidate is less than 18 years

• A test subject candidate is not able to understand the study or is not legally competent

• A test subject candidate has Ehlers-Danlos syndrome or Marfan syndrome

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiovascular Diseases

Intervention

Diagnostic Test:
• Noninvasive pulse wave analysis sensor, ECG-sensor
The sensors are noninvasively attached

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University, Tampere University of Technology

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave change from baseline during EVAR measured by a force sensor	A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave	2 hours
Primary	Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor	Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements	2 hours
Secondary	Pulse wave change from baseline after EVAR measured by a force sensor	A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave	30 days
Secondary	Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor	Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements	30 days
Secondary	Pulse wave change from baseline after EVAR measured by a force sensor	A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave	12 months
Secondary	Pulse wave change from baseline after EVAR measured by a optical	Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements	12 months