Heart Failure
Conditions
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.
Interventions
OTHERHeartInsight 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
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of WHF Hospitalization After HeartInsight Activation | through study completion, an average of 1.5 years | Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active. A worsening heart failure hospitalization event was defined according to ACC/AHA cardiovascular endpoint standards (Hicks et al., JACC 2015) as an urgent hospitalization for heart failure that included new or worsening heart failure symptoms, objective clinical evidence of worsening heart failure, and initiation or intensification of heart failure-specific treatment. |
Countries
Czechia, France, Hungary, Latvia, Portugal
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 100 |
| other Total, other adverse events | 6 / 100 |
| serious Total, serious adverse events | 27 / 100 |
Outcome results
None listed