Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Study Details
Study Description
Brief Summary
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: all patients
|
Device: BIOMONITOR III and BIOMONITOR IIIm
Insertion of BIOMONITOR III or BIOMONITOR IIIm
three scheduled in-office follow-ups
48-hour Holter ECG
|
Outcome Measures
Primary Outcome Measures
- SADE-free rate until the 3-month follow-up [3 months]
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
Secondary Outcome Measures
- R-wave amplitude [10 days to 4 weeks after insertion; 3-months]
The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.
- Noise burden [10 days to 4 weeks after insertion; 3-months]
The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.
- Assessment of P-wave visibility [10 days to 4 weeks after insertion; 3-months]
The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.
- SADE-free rate until the 12-month follow-up [12-months]
The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient is at high risk of developing a clinically important cardiac arrhythmia; or
-
Patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
-
Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
-
Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
-
Patient is able to understand the nature of the study and able to provide written informed consent.
-
Patient is willing and able to perform all follow-up visits at the investigational site.
-
Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion Criteria:
-
Patient is implanted with an ICD or pacemaker.
-
Patient is pregnant or breast-feeding.
-
Patient is less than 18 years old.
-
Patient's life-expectancy is less than 12 months.
-
Patient is participating in another interventional clinical investigation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GenesisCare Wesley | Auchenflower | Australia | ||
| 2 | GenesisCare Bundaberg | Bundaberg | Australia | ||
| 3 | GenesisCare Doncaster | Doncaster East | Australia | ||
| 4 | Canberra Heart Rhythm Clinic | Garran | Australia | ||
| 5 | Prince of Wales Hospital | Randwick | Australia | ||
| 6 | Princess Alexandra Hospital | Woolloongabba | Australia | ||
| 7 | Kepler Universitätsklinikum | Linz | Austria | ||
| 8 | Klinikum Wels-Grieskirchen | Wels | Austria | ||
| 9 | Allgemeines Krankenhaus der Stadt Wien (AKH) | Wien | Austria | ||
| 10 | Regionshospitalet Viborg | Viborg | Denmark | ||
| 11 | RHÖN-KLINIKUM Campus Bad Neustadt | Bad Neustadt An Der Saale | Germany | ||
| 12 | Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany | ||
| 13 | Städtisches Klinikum Dresden-Friedrichstadt | Dresden | Germany | ||
| 14 | Universitätsklinik an der Technischen Universität Dresden | Dresden | Germany | ||
| 15 | SRH Wald-Klinikum Gera GmbH | Gera | Germany | ||
| 16 | Universitätsklinikum Gießen und Marburg GmbH (UKGM) | Giessen | Germany | ||
| 17 | Ernst-Moritz-Arndt-Universität Greifswald | Greifswald | Germany | ||
| 18 | Klinikum St. Georg gGmbH | Leipzig | Germany | ||
| 19 | Klinikum Leverkusen Service GmbH | Leverkusen | Germany | ||
| 20 | St.-Marien-Hospital GmbH | Lünen | Germany | ||
| 21 | Johannes Wesling Klinikum Minden | Minden | Germany | ||
| 22 | Hospital del Bierzo | León | Spain | ||
| 23 | Complejo Hospitalario de Ourense | Ourense | Spain | ||
| 24 | Hospital Universitario Marques de Valdecilla | Santander | Spain | ||
| 25 | CHUV - Centre Hospitalier Universitaire Vaudoise | Lausanne | Switzerland | ||
| 26 | Fondazione Cardiocentro Ticino | Lugano | Switzerland | ||
| 27 | Kantonsspital St. Gallen | Saint Gallen | Switzerland |
Sponsors and Collaborators
- Biotronik SE & Co. KG
Investigators
- Principal Investigator: Thomas Deneke, Prof. Dr., RHÖN-KLINIKUM Campus Bad Neustadt, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA109