Status:
TERMINATED
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- Patients with irregular ventricular rhythm due to atrial tachycardia
- Pregnant or breast-feeding women
- Participation in an interventional clinical investigation
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03314675
Start Date
February 26 2018
End Date
July 6 2018
Last Update
November 28 2018
Active Locations (7)
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1
Ceske Budejovice hospital
České Budějovice, Czechia, 37001
2
Institute for Clinical and Experimental Medicine
Prague, Czechia, 14021
3
Herz- und Diabetiszentrum NRW
Bad Oeynhausen, Germany, 32545
4
SRH Waldklinikum Gera GmbH
Gera, Germany