Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
950 participants
INTERVENTIONAL
2005-07-31
2007-06-30
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
TREATMENT
SINGLE
Interventions
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Pacemaker with Automatic Capture
Eligibility Criteria
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Inclusion Criteria
* Patients who will be programmed to a pacing mode of DDD, DDDR, VVI, VVIR, or VDD at the time of implant
* Patients who sign and date a Patient Informed Consent form at or prior to the implant visit
* Patients who remain in the clinical care of the enrolling physician in approved centers
Exclusion Criteria
* Patients who have chronic leads with a ventricular threshold of more than 4.0 V
* Patients whose life expectancy is less than 12 months
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the ULTRA study.
* Patients who are younger than 18 years of age
* Patients who are pregnant
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Principal Investigators
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Bruce Koplan, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Choi HY, Noh YH, Jin SJ, Kim YH, Kim MJ, Sung H, Jang SB, Lee SJ, Bae KS, Lim HS. Bioavailability and tolerability of combination treatment with revaprazan 200 mg + itopride 150 mg: a randomized crossover study in healthy male Korean volunteers. Clin Ther. 2012 Sep;34(9):1999-2010. doi: 10.1016/j.clinthera.2012.07.004. Epub 2012 Aug 1.
Other Identifiers
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CR-CA-051205-B
Identifier Type: -
Identifier Source: org_study_id