Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1962 participants
INTERVENTIONAL
2005-07-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Implantable Cardioverter Defibrillator - Boston Scientific
VITALITY 2 ICD
VITALITY 2 Implantable Cardioverter Defibrillator
VITALITY 2 ICD
Implantable Cardioverter Defibrillator - Medtronic
Selected Medtronic family ICD
Medtronic Implantable Cardioverter Defibrillator
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
Interventions
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VITALITY 2 Implantable Cardioverter Defibrillator
VITALITY 2 ICD
Medtronic Implantable Cardioverter Defibrillator
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD
Eligibility Criteria
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Inclusion Criteria
* Patients who sign and date a Patient Informed Consent form prior to the implant visit
* Patients who remain in the clinical care of the enrolling physician in approved centers
* Patients who are able to tolerate ICD programming as specifically prescribed in the study protocol
Exclusion Criteria
* Patients whose life expectancy is less than 12 months
* Patients who have other cardiac surgeries or procedures planned but not yet performed during the duration of the study
* Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
* Patients who are pregnant or plan to become pregnant during the study
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Gold, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Ron Berger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Berger RD, Lerew DR, Smith JM, Pulling C, Gold MR. The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators. J Cardiovasc Electrophysiol. 2006 Jul;17(7):749-53. doi: 10.1111/j.1540-8167.2006.00463.x.
Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID Going Head to Head Trial. Heart Rhythm. 2012 Mar;9(3):370-7. doi: 10.1016/j.hrthm.2011.10.004. Epub 2011 Oct 4.
Other Identifiers
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RIGHT
Identifier Type: -
Identifier Source: secondary_id
CR-CA-032105-T
Identifier Type: -
Identifier Source: org_study_id
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