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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701467
First Posted: June 19, 2008
Last Update Posted: November 19, 2013
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.
Information provided by (Responsible Party):
Prof. Michael Glikson, Sheba Medical Center
  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 Prof. Michael Glikson, Sheba Medical Center:

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

Enrollment: 50
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation

  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00701467


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

Responsible Party: Prof. Michael Glikson, Director , Davidai Arrhythmia Center, Leviev Heart Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00701467     History of Changes
Other Study ID Numbers: SHEBA-4743-07-MG-CTIL
First Submitted: June 18, 2008
First Posted: June 19, 2008
Last Update Posted: November 19, 2013
Last Verified: November 2013

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

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