BIOSTREAM.HF HeartInsight

NCT05761249 | Completed

• 1 other identifier: CR033
• Study Type: observational
• Target: 100
• Locations: 5 countries
• Sites: 7

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (7)

Nemocnice Ceske Budejovice, a.s.

České Budějovice, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, Czechia

Location

CHU de Brest

Brest, France

Location

Semmelweis University

Budapest, Hungary

Location

The University of Pécs

Pécs, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 9, 2023
• Study Start: May 2, 2023
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); FR (1); HU (2); CZ (2); LA (1)