Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients (HRV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701467
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):
Prof. Michael Glikson, Sheba Medical Center

Brief Summary:
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.

Condition or disease
Ventricular Tachyarrhythmia

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia
Study Start Date : March 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Change in RR interval recorded by ICD [ Time Frame: within an hour before ventricular tachyarrythmia ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICD clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701467

Arrythmia Service Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Michael Glikson, MD SHEBA MC

Responsible Party: Prof. Michael Glikson, Director , Davidai Arrhythmia Center, Leviev Heart Center, Sheba Medical Center Identifier: NCT00701467     History of Changes
Other Study ID Numbers: SHEBA-4743-07-MG-CTIL
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Prof. Michael Glikson, Sheba Medical Center:
ICD implanted patients

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes