NCT05761249Completed
BIOSTREAM.HF HeartInsight
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 7 Feb 2023
- Start date
- 2 May 2023
- Primary completion date
- 9 Jul 2025
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure
- NCT number
- NCT05761249
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 2 May 2023 to the primary completion date, 9 Jul 2025
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of patient incompliance
Other
- Patient with permanent atrial fibrillation or 100% atrial pacing
- Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| The University of Pécs Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Hospital De Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.