OPTIMA Bi-ventricular Capture Verification Study | NCT00887055

Studies
OPTIMA Bi-ventricular Capture Verification Study

NCT00887055

Sponsor

Guidant Corporation

Status

Withdrawn

Last Update Posted

Jun 29, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

CRT device

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

never started

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 22, 2009

First Submission Date that Met QC Criteria

Apr 22, 2009

First Posted Date

Apr 23, 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

Jun 26, 2015

Last Update Posted Date

Jun 29, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device.

Detailed Description

morphology of EGM during loss of capture in either right ventricle (RV) or left ventricle (LV) at different AV delays and LV offsets and during exercise. These EGM signals will be used to design and develop improved automatic threshold and automatic capture algorithms for CRT defibrillators (CRT-D). As well, the data collected from the study will be used to to develop other automatic algorithms for CRT-D, such as pacing parameter optimization.

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

0Actual

Name	Type	Description	Arm Group Labels	Other Names
CRT device	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent indicating a willingness to participate, have indications for and have been implanted with a Guidant Renewal 4 CRT-D device

Exclusion Criteria:

Patients in atrial fibrillation that cannot be cardioverted for the study, sustained uncontrolled ventricular tachycardia (VT), sinus rhythm < 40 bpm or > 100 bpm, complete AV node block, AV node ablation, Severe aortic valve stenosis (valve area < 1.0 cm squared), frequent ectopic beats that would preclude adequate testing, lead in the great cardiac vein, women who are pregnant or who plan to become pregnant.

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francois Philippon, MD	Hopital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5 418-656-8711	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Laval		Ste-Foy	Quebec	G1V 4G5	Canada

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases