OPTIMA Bi-Ventricular Capture Verification Study

This study has been withdrawn prior to enrollment.
(never started)
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00887055
First received: April 22, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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:

Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00887055     History of Changes
Other Study ID Numbers: OPTIMA
Study First Received: April 22, 2009
Last Updated: April 22, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014