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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael Glikson, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00701467
First received: June 18, 2008
Last updated: November 17, 2013
Last verified: November 2013
  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 ]

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

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

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

No publications provided

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
Study First Received: June 18, 2008
Last Updated: November 17, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
ICD
ICD implanted patients

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

ClinicalTrials.gov processed this record on April 17, 2014