Bi-ventricular Capture Verification Study

Guidant Corporation1 site in 1 countryApril 23, 2009

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Guidant Corporation
Locations: 1
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 23, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Guidant Corporation

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.