NCT01725568

Brief Summary

The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

November 6, 2012

Last Update Submit

November 19, 2014

Conditions

ATRIAL FIBRILLATION, Syncope

Outcome Measures

Primary Outcomes (2)

  • SADE free-rate

    SADE free-rate \> 90% at 3 month follow-up

    at 3 month follow-up

  • Rate of appropriate QRS detection

    Rate of appropriate QRS detection \> 90% (based on comparison with Holter ECG recording)

    at 6 week follow-up

Other Outcomes (2)

  • Sensitivity and Positive Predictive of episode detection

    1 year

  • Adverse events

    1 year

Study Arms (1)

Implantable cardiac monitor diagnostics

Patients has standard indication for implantable cardiac monitor diagnostic.

Device: BioMonitor

Interventions

BioMonitorDEVICE

Implantable cardiac monitor

Implantable cardiac monitor diagnostics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with standard ICM indication who are referred to the hospital

You may qualify if:

  • Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.

You may not qualify if:

  • Implanted ICD or cardiac pacemaker
  • Allergy to patch electrodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock

Rostock, 18057, Germany

Location

MeSH Terms

Conditions

Atrial FibrillationSyncope

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Dietmar Baensch, Professor

    University of Rostock, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

DE(1)