ELECTION - The Electrode Configuration Cardiac Resynchron... | NCT00848653

Studies
ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)

NCT00848653

Sponsor

Guidant Corporation

Status

Completed

Last Update Posted

Feb 20, 2009Estimated

Enrollment

260Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

CRT device

Countries

Not provided

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 2009

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

Nov 2004

Primary Completion Date

Sep 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Feb 19, 2009

First Submission Date that Met QC Criteria

Feb 19, 2009

First Posted Date

Feb 20, 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 19, 2009

Last Update Posted Date

Feb 20, 2009Estimated

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 ELECtrode configuraTION CRT Study (ELECTION)

Detailed Description

Cardiac resynchronization therapy (CRT) is an accepted treatment for selected heart failure patients. This therapy is delivered using a device (pacemaker (PM) +/- defibrillator (ICD) ) and leads placed in the right atrium (RA), right ventricle (RV) and left ventricle (LV). Rates of LV lead implantation failure and post operative lead related have decreased dramatically over the years, however, the incidence of lead dislodgement and phrenic nerve stimulation is still high. This study is a prospective evaluation of the benefits of having various pace/sense electrode configurations available in a CRT system.

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

260Actual

Name	Type	Description	Arm Group Labels	Other Names
CRT device	Device	market approved CRT device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to test and compare all available LV pacing and sensing configurations		6 months

Secondary Outcomes

Measure	Description	Time Frame
to track all programming changes made to the LV pacing/sensing configurations		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients selected for a Guidant system, symptomatic heart failure, LV dysfunction, QRS width > 120 ms, > or = 18 yrs, able to understand the procedure, available for follow-up.

Exclusion Criteria:

< 18 years, life expectancy < 6 months, expectation of heart transplantation during the study period, patients who have or are likely to receive a mechanical tricuspid valve, documented aortic stenosis, hypertrophic obstructive cardiomyopathy, inability or refusal to complete the follow-up at an approved centre, enrollment in another cardiovascular clinical investigation unless approved by the Manager of Clinical Studies, Guidant Canada, inability or refusal to sign consent.

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 indicated for CRT therapy

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jean Champagne, MD	Hopital Laval	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21273196	Derived	Champagne J, Healey JS, Krahn AD, Philippon F, Gurevitz O, Swearingen A, Glikson M; ELECTION Investigators. The effect of electronic repositioning on left ventricular pacing and phrenic nerve stimulation. Europace. 2011 Mar;13(3):409-15. doi: 10.1093/europace/euq499. Epub 2011 Jan 26.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases