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OPTIMA Bi-ventricular Capture Verification Study

This study has been withdrawn prior to enrollment.
(never started)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887055
First Posted: April 23, 2009
Last Update Posted: June 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guidant Corporation
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887055


Locations
Canada, Quebec
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Francois Philippon, MD Hopital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5 418-656-8711
  More Information

ClinicalTrials.gov Identifier: NCT00887055     History of Changes
Other Study ID Numbers: OPTIMA
First Submitted: April 22, 2009
First Posted: April 23, 2009
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases