BIOSTREAM.HF HeartInsight

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761249
• Other study ID #: CR033
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Biotronik SE & Co. KG
• Contact: Andreas Peth, Dr.
• Phone: +49-30-689051288
• Email: heartinsight-stream[@]biotronik.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Country	Name	City	State
Czechia	Nemocnice Ceske Budejovice, a.s.	Ceské Budejovice
Czechia	Fakultní nemocnice Olomouc	Olomouc
France	CHU de Brest	Brest
Hungary	Semmelweis University	Budapest
Hungary	The University of Pécs	Pécs
Latvia	Pauls Stradins Clinical University Hospital	Riga
Portugal	Hospital de Santa Maria	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Czechia,  France,  Hungary,  Latvia,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of WHF hospitalization after HeartInsight activation	Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active	through study completion, an average of 1.5 years