BIOSTREAM.HF HeartInsight

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.

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fakultní nemocnice Olomouc, Olomouc, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient willing and able to give consent
Participation in BIO|STREAM.HF
HeartInsight-capable CRT-D device implanted or planned to be implanted
Symptomatic heart failure NYHA class II or III within 45 days prior to enrollment
HeartInsight score available or planned use of HeartInsight
History of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure
Patient is willing and able to utilize BIOTRONIK Home Monitoring via CardioMessenger and has sufficient mobile network coverage

Exclusion criteria

Patient with permanent atrial fibrillation or 100% atrial pacing
Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated
History of patient incompliance

Treatment and study plan

HeartInsight activation

Other

HeartInsight is activated at enrollment. The attending physicians are free on how to integrate HeartInsight in the patient care. Any treatment is based on routine care according to guidleines. Only documentation occurs on how the physicians use HeartInsight and actions taken in response to HeartInsight alerts

Primary outcomes

Rate of WHF hospitalization after HeartInsight activation

Time frame: through study completion, an average of 1.5 years

Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Mar 9, 2023
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed