Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients
HRV
HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia
1 other identifier
observational
50
1 country
1
Brief Summary
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2008
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedNovember 19, 2013
November 1, 2013
2 years
June 18, 2008
November 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in RR interval recorded by ICD
within an hour before ventricular tachyarrythmia
Study Arms (1)
Observation
Eligibility Criteria
ICD clinic
You may qualify if:
- S/P lexos VR/-T,DR/-T implantation
- Signed patient informed consent
You may not qualify if:
- CAF
- Life expectancy\<6 months
- Impending heart transplant
- Persistent recurring tachycardia
- Rhythm disturbances that preclude a meaningful HRV analysis
- Participation in another study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arrythmia Service Center
Ramat Gan, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Glikson, MD
SHEBA MC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director , Davidai Arrhythmia Center, Leviev Heart Center
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11