Optimal EGM Configuration for Morphology Discrimination | NCT00888667

Studies
Optimal EGM Configuration for Morphology Discrimination

NCT00888667

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Premature Ventricular Complexes

Interventions

Pacing interventions

Countries

Canada

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patient population was not available

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 27, 2009Estimated

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

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Name	Class
Unity Health Toronto	OTHER

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 study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.

Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.

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

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICD patient with frequent PVCs			Other: Pacing interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacing interventions	Other	10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% morphology match	off line analysis	acute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
Patients must be willing to sign an informed consent form.
Patients must have frequent PVCs (minimum of 30/hour)

Exclusion Criteria:

Known history of slow VT (under 160 bpm).
Patients under the age of 18 years.
Pregnant women.
Pacemaker dependent rhythm.
Ongoing angina pectoris.
Current NYHA Class 3-4 heart failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a dual chamber ICD and frequent PVCs

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Michael's Hospital		Toronto	Ontario	M5B1W8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D018879	Ventricular Premature Complexes

Ancestor Terms

ID	Term
D005117	Cardiac Complexes, Premature
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided