Change in Heart Rate Variability Prior to Tachyarrhythmia... | NCT00701467

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

NCT00701467

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Nov 19, 2013Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Ventricular Tachyarrhythmia

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jun 18, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2013

Last Update Posted Date

Nov 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Michael Glikson, Director , Davidai Arrhythmia Center, Leviev Heart Center, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Observation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

ICD clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Glikson, MD	SHEBA MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arrythmia Service Center		Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D017180	Tachycardia, Ventricular

Ancestor Terms

ID	Term
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided