Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Recruiting

• Conditions: Bradycardia; Syncope; Cryptogenic Stroke; Tachycardia; Atrial Fibrillation

• Registration Number: NCT04075084
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Start: 2019-10-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2027-09-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)
• Patient is able to understand the nature of the registry and to provide written informed consent.
• Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria

• Patient is pregnant or breast feeding.
• Patient is less than 18 years old.
• Patient is participating in another interventional clinical investigation other than the submodules of BIO|STREAM.ICM

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to diagnosis	Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).	Device is intended to detect rare arrhythmias. Time to detect this relevant arrhytmia will be recorded.

Secondary Outcome Measures

Name	Time	Method
Insertion procedure and success	It is considered that all patients are enrolled and subsequently inserted with the investigational device within 2 years after study start, i.e. until October 2021. Exchanges will be also considered for analysis	Information on the Insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and inserton tool); Success rate of insertions.

Trial Locations

Locations (29)

Integral Health; 🇦🇺 Adelaide, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Hôpital Saint-André; 🇫🇷 Bordeaux, France

Le Centre Hospitalier Universitaire de Brest (CHRU Brest); 🇫🇷 Brest, France

Le Centre Hospitalier Universitaire de Caen (CHRU Caen); 🇫🇷 Caen, France

Le Centre Hospitalier Universitaire de Tours (CHRU Tours); 🇫🇷 Chambray-lès-Tours, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hôpital Haut Lévêque (CHU); 🇫🇷 Pessac Cedex, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

St. Marienkrankhaus Klinikum Westmünsterland GmbH; 🇩🇪 Ahaus, Germany

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