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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00366158 |
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Date of registration:
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18/08/2006 |
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Primary sponsor: |
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Public title:
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EVITA: Evaluation of VIP Feature in Pacemaker Patients
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Scientific title:
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EVITA: Evaluation of VIP Feature in Pacemaker Patients |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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461 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00366158 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Sweden
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Contacts
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Name:
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Charles Kennergren, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahlgrenska University Hospital, Sweden |
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Name:
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Alexander Bauer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätskliniken Heidelberg, Heidelberg, 69115, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient has an indication for implantation of a dual-chamber pacemaker;
- Patient is implanted or scheduled to be implanted with a St Jude Medical Victory
pacemaker, or newer device with the same study relevant feature.
Exclusion Criteria:
- Patient has persistent or permanent AF/AFl;
- Patient has permanent AV Block;
- Patient has a pacemaker replacement;
- Patient is in NYHA class IV;
- Patient is unable to attend the follow-up visits;
- Patient is pregnant;
- Patient is less than 18 years of age
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arrhythmia
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Intervention(s)
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Device: Device: St. Jude Medical Victory dual-chamber pacemaker
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Device: Ventricular Intrinsic Preference
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Primary Outcome(s)
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Percentage of ventricular pacing
[Time Frame: 6 and 12 months]
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Secondary ID(s)
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CR06001LV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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