Heart Failure
Conditions
Keywords
CRT-D, LV Latency
Brief summary
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data
Interventions
DEVICEBIOTRONIK CRT-D
Pre-specified follow-up and measurements
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date * Patient successfully implanted with a left ventricular lead * High likelihood of LV latency ≥ 40 ms * LV lead in lateral or postero-lateral position in the coronary venous system * Patient is able to understand the nature of the clinical investigation * Patient is willing to undergo the required measurements at the investigation site * Patient provides written informed consent * Age ≥ 18 years
Exclusion criteria
* Patients with irregular ventricular rhythm due to atrial tachycardia * Pregnant or breast-feeding women * Participation in an interventional clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Device-base measured LV latency in the LV IEGM channel and Far Field channel | 1 day |
| 12-lead ECG-measured LV latency in the channel with earliest QRS onset | 1 day |
| Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel | 1 day |
| 12-lead ECG-measured latency intervals | 1 day |
Countries
Czechia, Germany, Netherlands
Outcome results
None listed