OPTIMA Bi-ventricular Capture Verification Study

NCT00887055 | Withdrawn

• 1 other identifier: OPTIMA
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Interventions

CRT device DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guidant Corporation: lead

Study Sites (1)

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Francois Philippon, MD

  Hopital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5 418-656-8711

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

CA (1)