Study Stopped
Unsuccessful enrollment
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
BIO|PULSE
1 other identifier
interventional
16
3 countries
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Feb 2018
Shorter than P25 for not_applicable heart-failure
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedStudy Start
First participant enrolled
February 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2018
CompletedNovember 28, 2018
November 1, 2018
4 months
October 16, 2017
November 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
1 day
Secondary Outcomes (4)
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
Study Arms (1)
CRT-D Measurements
OTHERPre-specified measurements and additional follow-ups
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with irregular ventricular rhythm due to atrial tachycardia
- Pregnant or breast-feeding women
- Participation in an interventional clinical investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Ceske Budejovice hospital
České Budějovice, 37001, Czechia
Institute for Clinical and Experimental Medicine
Prague, 14021, Czechia
Herz- und Diabetiszentrum NRW
Bad Oeynhausen, 32545, Germany
SRH Waldklinikum Gera GmbH
Gera, Germany
Universitätsklinikum Gießen und Marburg
Giessen, 35392, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
The Erasmus University Medical Center
Rotterdam, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Nordbeck, PD Dr.
Wuerzburg University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2017
First Posted
October 19, 2017
Study Start
February 26, 2018
Primary Completion
June 28, 2018
Study Completion
July 6, 2018
Last Updated
November 28, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share