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OPTIMA Bi-ventricular Capture Verification Study

This study has been withdrawn prior to enrollment.
(never started)
Information provided by:
Guidant Corporation Identifier:
First received: April 22, 2009
Last updated: June 26, 2015
Last verified: June 2015
The purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device.

Condition Intervention Phase
Heart Failure Device: CRT device Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bi-ventricular Capture Verification Study

Further study details as provided by Guidant Corporation:

Enrollment: 0
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00887055

Canada, Quebec
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Guidant Corporation
Principal Investigator: Francois Philippon, MD Hopital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5 418-656-8711
  More Information Identifier: NCT00887055     History of Changes
Other Study ID Numbers: OPTIMA
Study First Received: April 22, 2009
Last Updated: June 26, 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on June 23, 2017