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Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
NA trial testing BIOMONITOR III and BIOMONITOR IIIm in Tachyarrhythmia in 167 participants. Completed in 6 April 2022.
| Lead sponsor | Biotronik SE & Co. KG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 167 |
| Start date | 17 October 2019 |
| Primary completion | 30 June 2021 |
| Estimated completion | 6 April 2022 |
| Sites | 27 locations across Denmark, Austria, Germany, Switzerland, Australia, Spain |
Biotronik SE & Co. KG — full company profile →
Adults 18 to 99, any sex, with Tachyarrhythmia or Atrial Fibrillation (AF). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 141 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Patients |
|---|---|---|
| Atrial fibrillation | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Atrioventricular block complete | Cardiac disorders | — |
| Bradycardia | Cardiac disorders | — |
| Adverse drug reaction | General disorders | — |
| Syncope | Nervous system disorders | — |
| Sinus arrest | Cardiac disorders | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Sinus node dysfunction | Cardiac disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Atrial flutter | Cardiac disorders | — |
| Mitral valve incompetence | Cardiac disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — |
| Circulatory collapse | Vascular disorders | — |
| Condition aggravated | General disorders | — |
| Corona virus infection | Infections and infestations | — |
| Coronary artery stenosis | Cardiac disorders | — |
| Device dislocation | Product Issues | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Ejection fraction decreased | Investigations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Headache | Nervous system disorders | — |
| Implant site pain | General disorders | — |
| Ischaemic cerebral infarction | Nervous system disorders | — |
| Reaction | System | All Patients |
|---|---|---|
| Adverse drug reaction | General disorders | — |
| Chest pain | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Implant site haematoma | General disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Syncope | Nervous system disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Bradycardia | Cardiac disorders | — |
| Chest discomfort | General disorders | — |
| Device physical property issue | Product Issues | — |
| Dizziness | Nervous system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Heart rate increased | Investigations | — |
| Implant site bruising | General disorders | — |
| Implant site haemorrhage | General disorders | — |
| Malaise | General disorders | — |
| Oversensing | Product Issues | — |
| Sinus tachycardia | Cardiac disorders | — |
| Supraventricular extrasystoles | Cardiac disorders | — |
| Undersensing | Product Issues | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Amnesia | Nervous system disorders | — |
| Antisynthetase syndrome | Musculoskeletal and connective tissue disorders | — |
| Anxiety disorder | Psychiatric disorders | — |
| Balance disorder | Nervous system disorders | — |
| Blood potassium decreased | Investigations | — |
| Cardiac arrest | Cardiac disorders | — |
| Chronic gastritis | Gastrointestinal disorders | — |
| Condition aggravated | General disorders | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Deafness | Ear and labyrinth disorders | — |
| Device dislocation | Product Issues | — |
| Epilepsy | Nervous system disorders | — |
| Eye haemorrhage | Eye disorders | — |
| Facial bones fracture | Injury, poisoning and procedural complications | — |
| Fatigue | General disorders | — |
| Gastroenteritis | Infections and infestations | — |
Most-reported serious reactions: Atrial fibrillation, Cardiac arrest, Atrioventricular block complete, Bradycardia, Adverse drug reaction, Syncope, Sinus arrest, Ventricular tachycardia.
Data from ClinicalTrials.gov NCT04025710 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04025710.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing