Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05761249

BIOSTREAM.HF HeartInsight

Sponsor: Biotronik SE & Co. KG

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-05-02

Completion Date

2025-07-09

Last Updated

2026-09-09

Healthy Volunteers

No

Conditions

Interventions

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

Locations (7)

Nemocnice Ceske Budejovice, a.s.

České Budějovice, Czechia

Fakultní nemocnice Olomouc

Olomouc, Czechia

CHU de Brest

Brest, France

Semmelweis University

Budapest, Hungary

The University of Pécs

Pécs, Hungary

Pauls Stradins Clinical University Hospital

Riga, Latvia

Hospital de Santa Maria

Lisbon, Portugal