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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014