NCT04075084 (BIOSTREAM-ICM) is a clinical trial in Tachycardia, sponsored by Biotronik SE & Co. KG.

Who is sponsoring NCT04075084?

NCT04075084 is sponsored by Biotronik SE & Co. KG.

What condition does NCT04075084 study?

NCT04075084 studies Tachycardia, Atrial Fibrillation, Syncope, Bradycardia, Cryptogenic Stroke.

Is NCT04075084 still recruiting?

NCT04075084 is currently recruiting now. Last updated 1 October 2025.

Last reviewed 2025-10-01 · How we verify

NCT04075084: BIOSTREAM-ICM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Last updated 1 October 2025

What this trial tests

trial in Tachycardia in 1,400 participants. Currently enrolling.

Timeline

28 October 2019

Primary endpoint
30 May 2027

30 August 2027

Quick facts

Lead sponsor	Biotronik SE & Co. KG
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,400
Start date	28 October 2019
Primary completion	30 May 2027
Estimated completion	30 August 2027
Sites	31 locations across France, Italy, Germany, Switzerland, Australia, Portugal, Latvia, Spain

Conditions studied

Tachycardia — all drugs for Tachycardia →
Atrial Fibrillation — all drugs for Atrial Fibrillation →
Syncope — all drugs for Syncope →
Bradycardia — all drugs for Bradycardia →

Sponsor

Biotronik SE & Co. KG — full company profile →

Who can join

18 and older, any sex, with Tachycardia or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population.
Deneke T, Cabanas P, Hofer D, Gaspar T, et al · · 2022 · cited 12× · PMID 35496450 · DOI 10.1016/j.hroo.2022.01.010
Diagnostic yield of an insertable cardiac monitor in a large patient population.
Lau DH, Pierre B, Cabanas P, Martens E, et al · · 2023 · cited 8× · PMID 36873314 · DOI 10.1016/j.hroo.2022.11.005
Implantable cardiac monitors: artificial intelligence and signal processing reduce remote ECG review workload and preserve arrhythmia detection sensitivity.
Bisignani G, Cheung JW, Rordorf R, Kutyifa V, et al · · 2024 · cited 6× · PMID 38322767 · DOI 10.3389/fcvm.2024.1343424
Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.
Bisignani G, De Bonis S, Pierre B, Lau DH, et al · · 2023 · cited 4× · PMID 37025684 · DOI 10.3389/fcvm.2023.1148052
Changes in R-wave amplitude at implantation are associated with gender and orientation of insertable cardiac monitor: observations from the confirm Rx™ body posture and physical activity study.
Swale M, Paul V, Delacroix S, Young G, et al · · 2022 · cited 3× · PMID 36209063 · DOI 10.1186/s12872-022-02752-0
Sudden arrhythmic death in patients with syncope and implantable cardiac monitor.
Cabanas Grandío P, Pierre B, Bisignani G, Cuneo A, et al · · 2024 · PMID 39651448 · DOI 10.1016/j.hroo.2024.09.002

Verify or expand the search:

Other recruiting trials for Tachycardia

Currently open trials in the same condition.

NCT07018648 — Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System · NA · recruiting
NCT06637904 — TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections · NA · recruiting
NCT06892938 — Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring · active not recruiting
NCT06048731 — Enlighten Study: The EV-ICD Post Approval Registry · active not recruiting
NCT06505668 — Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial. · NA · recruiting

Other Biotronik SE & Co. KG trials

Trials by the same sponsor.

NCT07393009 — Studying Routine Patient Care With BIOTRONIK Devices That Allow a More Natural Heart Stimulation · not yet recruiting
NCT06989580 — BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specif · NA · recruiting
NCT06018818 — Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family · NA · completed
NCT05426785 — To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP) · NA · recruiting
NCT05761249 — BIOSTREAM.HF HeartInsight · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04075084 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biotronik SE & Co. KG
Last refreshed: 1 October 2025

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/NCT04075084.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing