Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients (HRV)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Sheba Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Sheba Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00701467
First received: June 18, 2008
Last updated: July 14, 2008
Last verified: June 2008
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Purpose
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.
| Condition |
|---|
|
Ventricular Tachyarrhythmia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia |
Resource links provided by NLM:
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- Change in RR interval recorded by ICD [ Time Frame: within an hour before ventricular tachyarrythmia ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2011 |
| Groups/Cohorts |
|---|
| Observation |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
ICD clinic
Criteria
Inclusion Criteria:
- S/P lexos VR/-T,DR/-T implantation
- Signed patient informed consent
Exclusion Criteria:
- CAF
- Life expectancy<6 months
- Impending heart transplant
- Persistent recurring tachycardia
- Rhythm disturbances that preclude a meaningful HRV analysis
- Participation in another study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701467
Contacts
| Contact: Michael Glikson, MD | 972-3-530-2608 | mglikson@post.tau.ac.il |
Locations
| Israel | |
| Arrythmia Service Center | Recruiting |
| Ramat Gan, Israel | |
| Principal Investigator: Michael Glikson, MD | |
| Sub-Investigator: Roy Beinart, MD | |
| Sub-Investigator: David Luria, MD | |
| Sub-Investigator: Osnat Gurevitz, MD | |
| Sub-Investigator: David Bar Lev, MD | |
Sponsors and Collaborators
Sheba Medical Center
Investigators
| Principal Investigator: | Michael Glikson, MD | SHEBA MC |
More Information
No publications provided
| Responsible Party: | Prof. Glikson Michael, SHEBA MC |
| ClinicalTrials.gov Identifier: | NCT00701467 History of Changes |
| Other Study ID Numbers: | SHEBA-4743-07-MG-CTIL |
| Study First Received: | June 18, 2008 |
| Last Updated: | July 14, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
ICD ICD implanted patients |
Additional relevant MeSH terms:
|
Tachycardia, Ventricular Tachycardia Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013