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NCT00887055 Clinical Trial

OPTIMA Bi-ventricular Capture Verification Study

Heart Failure Clinical Trial

Official title:
Bi-ventricular Capture Verification Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00887055
Other study ID # OPTIMA
Secondary ID
Status Withdrawn
Phase Phase 4
First received April 22, 2009
Last updated June 26, 2015

Study information
Verified date June 2015
Source Guidant Corporation
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• CRT device

Locations
Country Name City State
Canada Hopital Laval Ste-Foy Quebec

Sponsors (1)
Lead Sponsor Collaborator
Guidant Corporation

Country where clinical trial is conducted

Canada, 

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