Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients

Ventricular Tachyarrhythmia Clinical Trial

— HRV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701467
• Other study ID #: SHEBA-4743-07-MG-CTIL
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: November 17, 2013
• Start date: March 2008
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tachycardia, Ventricular
• Ventricular Tachyarrhythmia

Locations

Country	Name	City	State
Israel	Arrythmia Service Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in RR interval recorded by ICD		within an hour before ventricular tachyarrythmia	No