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

November 17, 2013 updated by: Prof. Michael Glikson, Sheba Medical Center

HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Arrythmia Service Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICD clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in RR interval recorded by ICD
Time Frame: within an hour before ventricular tachyarrythmia
within an hour before ventricular tachyarrythmia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Michael Glikson, MD, Sheba MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 17, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-4743-07-MG-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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