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HeartInsight activation / Heart Failure · Observational Study
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed observational registry study of HeartInsight, a remote monitoring and alert tool for heart failure patients with implanted BIOTRONIK devices. The registry record describes the study protocol and enrollment but contains no results; the planned primary outcome was rate of worsening heart failure hospitalizations over approximately 1.5 years, documented through ~150 device alerts and their clinical processing.
Observational. Heart Failure; age from 18 Years. Intervention: HeartInsight activation. n = 100. 7 sites across 5 countries.
This is a completed observational registry study of HeartInsight, a remote monitoring and alert tool for heart failure patients with implanted BIOTRONIK devices. The registry record describes the study protocol and enrollment but contains no results; the planned primary outcome was rate of worsening heart failure hospitalizations over approximately 1.5 years, documented through ~150 device alerts and their clinical processing.
No results are posted in this registry record; no efficacy, safety, or effectiveness data are reported
The source did not state who this applies to in practice.
Observational registry study of a monitoring tool in completed enrollment with no posted results; describes planned documentation of device alerts and clinical processing in routine care without efficacy outcomes reported.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05761249). This is a study registration, not published results. Lead sponsor: Biotronik SE & Co. KG. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 100 participants (ACTUAL). Conditions: Heart Failure. Interventions: OTHER: HeartInsight activation. Primary outcome measures: Rate of WHF Hospitalization After HeartInsight Activation , through study completion, an average of 1.5 years. Brief summary: The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.