D2-EPG Study: Evaluation of New Sensing Circuitry and Cap... | NCT00328705

Studies
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

NCT00328705

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Completed

Last Update Posted

Feb 13, 2008Estimated

Enrollment

65Actual

Phase

Not Applicable

Conditions

Heart Diseases

Interventions

Implantable Cardioverter Defibrillator

Countries

United States

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 2008

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

May 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

May 19, 2006

First Submission Date that Met QC Criteria

May 19, 2006

First Posted Date

May 22, 2006Estimated

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 11, 2008

Last Update Posted Date

Feb 13, 2008Estimated

Name	Class
Medtronic	INDUSTRY

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

This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Detailed Description

The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Name	Type	Description	Arm Group Labels	Other Names
Implantable Cardioverter Defibrillator	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.

Exclusion Criteria:

Patients who have 3rd degree heart block, as assessed by the investigator
Patients who have a mechanical tricuspid heart valve
Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Cole Hannon	Medtronic CRDM	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D006333	Heart Failure

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017147	Defibrillators, Implantable

Ancestor Terms

ID	Term
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Tampa	Florida		United States