Heart Failure
Conditions
Keywords
Pragmatic, Heart disease, ICD, CRT-D, Pacemaker, Registry, HeartLogic
Brief summary
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
Detailed description
The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.
Interventions
OTHERHeartLogic
HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.
Sponsors
Boston Scientific Corporation
Tor Biering-Sørensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to treatment allocation. Active-arm participants will be unblinded at the time of first HeartLogic alert.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization 2. Age ≥18 years 3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as not monitored
Exclusion criteria
There are no specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of hospitalization for heart failure or all-cause death (first event) | 42 months |
Secondary
| Measure | Time frame |
|---|---|
| Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events) | 42 months |
| Hospitalization for heart failure (first event) | 42 months |
| All-cause hospitalization | 42 months |
| All-cause mortality | 42 months |
Other
| Measure | Time frame |
|---|---|
| Hospitalization for atrial fibrillation | 42 months |
| Atrial fibrillation burden | 42 months |
| Hospitalization for cardiac arrest | 42 months |
| Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock | 42 months |
| Cardiovascular mortality | 42 months |
| Incident heart failure (among participants without heart failure at baseline) | 42 months |
| Days alive and out of hospital | 42 months |
| Length of hospital stay | 42 months |
| Hospitalizations for heart failure (recurrent events) | 42 months |
| HeartLogic alert rate | 42 months |
| Average HeartLogic index | 42 months |
| Median HeartLogic alert length | 42 months |
| % time in HeartLogic alert | 42 months |
| Maximal observed HeartLogic index | 42 months |
| Time from HeartLogic alert to clinical event | 42 months |
| Individual HeartLogic sensor trends | 42 months |
| Use of guideline-directed medical therapy for heart failure | 42 months |
| Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations | 42 months |
| All-cause readmission within 30 days after hospitalization for heart failure | 42 months |
| Hospitalization for any cardiovascular disease | 42 months |
| Hospitalization for any cardio-respiratory disease | 42 months |
Countries
Denmark
Contacts
Primary ContactNiklas Dyrby Johansen, MD
Backup ContactMarie Terese Barlebo Madsen, PhD
Outcome results
None listed