NCT05761249

BIOSTREAM.HF HeartInsight

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	HeartInsight activation	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

Timeline

• Start date: 2023-05-02
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2023-03-09
• Last updated: 2026-01-13

Locations

7 sites across 5 countries: Czechia, France, Hungary, Latvia, Portugal