BIO.MASTER.BioMonitor 2 Study

Atrial Fibrillation Clinical Trial

Official title:

Master Study of the Insertable Cardiac Monitor BioMonitor 2.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565238
• Other study ID #: BA105
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: May 5, 2017
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks.

• Patient is able to understand the nature of the study and provides written informed consent.

• Patient is able and willing to complete the planned follow-up visits at the investigational site.

• Patient accepts the Home Monitoring® concept.

• Age is = 18 years.

Exclusion Criteria:

• Patients implanted with ICD or pacemaker.

• Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded.

• Life expectancy of less than 6 months.

• Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Syncope
• Tachyarrhythmia
• Tachycardia

Intervention

Device:
• BioMonitor 2
Implantation of BioMonitor 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Device Effect (SADE)-free rate = 90% related to BioMonitor 2		3 month
Secondary	R-Wave amplitude = 0.3 mV		1 week