BIO.MASTER.BioMonitor 2 Study

NCT02565238 | Completed

• 1 other identifier: BA105
• Study Type: observational
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tachyarrhythmia; Atrial Fibrillation; Syncope

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2

  3 month

Secondary Outcomes (1)

• R-Wave amplitude ≥ 0.3 mV

  1 week

Interventions

BioMonitor 2 DEVICE

Implantation of BioMonitor 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient collective consists mainly of patients with indications of an insertable cardiac monitor or who are planned for loop recorded guided AF-therapy management. The investigator will select patients who are appropriate for particiation from his general patient population.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

MeSH Terms

Conditions

Tachycardia; Atrial Fibrillation; Syncope

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Christopher Piorkowski, MD

  Heart Center Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 1, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05