The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers

Liver Cirrhosis Clinical Trial

Official title:

The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers and/or Implantable Cardioverter-Defibrillators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415348
• Other study ID #: Bio 15-35
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2015
• Last updated: April 8, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2015
• Source: University of Saskatchewan
• Contact: Yin Chan, MD, PhD
• Phone: 3068805445
• Email: yin.chan[@]usask.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators. Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation at a teaching-hospital pacemaker clinic.

Description:

Assessment of liver fibrosis in patients with chronic liver diseases provides staging and prognostic information critical in establishing treatment priorities. The gold standard evaluation of liver fibrosis is hampered by the invasive nature of liver biopsies. FibroScan is a non-invasive alternative that has been extensively validated in chronic hepatitis C, chronic hepatitis B, alcoholic liver disease, and non- alcoholic fatty liver disease patients.

To avoid unknown risks of potential interaction, the manufacturer have advised against the use of the device in patients with active implantable medical device including cardiac pacemaker and/or implantable cardioverter-defibrillators(ICD). Review of the literature showed that these two population have been specifically excluded in all previously reported studies.

At the time of writing, no specific reports have demonstrated either safety or potential harm of the FibroScan in patients with pacemaker/ICD. Given the proven benefit of the FibroScan in chronic liver disease and the current policy of excluding patients with pacemaker/ICD in clinical practice, this study aims to formally evaluate the safe use of the FibroScan in this population within the controlled environment of a pacemaker lab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

-Any outpatient undergoing routine pacemaker interrogation at pacemaker clinic

Exclusion Criteria:

• Pregnancy

• BMI>35

• Person with active implantable medical devices other than cardiac pacemaker and/or ICD

• Person who are unable to tolerate lying flat for the FibroScan examination.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Device:
• Fibroscan

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Pacemaker/ICD malfunction		30 min	Yes
Primary	Type of Pacemaker/ICD malfunction		30 min	Yes