A Feasibility Study on Prediction of an ICD Shock by ICD-... | NCT01822145

Studies
A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data

NCT01822145

Sponsor

Princess Margaret Hospital, Hong Kong

Status

Unknown status

Last Update Posted

Sep 4, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Sudden Cardiac Arrest
Ventricular Tachycardia
Ventricular Fibrillation

Interventions

Countries

China

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Mar 24, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Apr 2, 2013Estimated

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

Sep 3, 2015

Last Update Posted Date

Sep 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ngai Yin Chan, Principal investigator, Princess Margaret Hospital, Hong KongPrincipal Investigator

Lead Sponsor

Princess Margaret Hospital, Hong KongOTHER_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

Description Module

Brief Summary

The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICD recipients		ICD recipients with documented cardiac arrest or ventricular arrhythmias	Device: ICD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICD	Device		ICD recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICD-derived T-wave alternans amplitude before ICD shock	The T-wave alternans amplitude before an ICD shock will be measured in mV and compared to the baseline T-wave alternans amplitude	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≧ 18 and ≦ 80
Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
Patients who are compliant to CareLink follow-up

Exclusion Criteria:

Patients who are pregnant
Patients who are incapable of giving consent to the study
Patients who have a life-expectancy of less than 2 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ngai Yin Chan, MBBS	Contact	852 2990 1111		ngaiyinchan@yahoo.com.hk

Overall Officials

Name	Affiliation	Role
Ngai Yin Chan, MBBS	Princess Margaret Hospital, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Hospital	Recruiting	Hong Kong		999077	China

Condition Browse Module

MeSH Terms

ID	Term
D016757	Death, Sudden, Cardiac
D017180	Tachycardia, Ventricular
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003645	Death, Sudden

Browse Leaves

Not provided

Browse Branches

Not provided