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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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14 January 2013 |
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Main ID: |
NCT01294839 |
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Date of registration:
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10/02/2011 |
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Primary sponsor: |
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Public title:
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Right Ventricular Outflow Tract Study
RVOTCARE |
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Scientific title:
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RIGHT VENTRICULAR OUTFLOW TRACT SEPTAL PACING FOR CARDIAC DYSFUNCTION PREVENTION EVALUATION |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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555 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01294839 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Lin Sh Wu, MD |
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Address:
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Telephone:
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+86 20 83827812 |
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Email:
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wushulin8888@yahoo.com.cn |
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Affiliation:
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Name:
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Lin Sh Wu, MD |
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Address:
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Telephone:
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+86 20 83827812 |
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Email:
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wushulin8888@yahoo.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with only sinus-node dysfunction and meet pacing indication
- Patients with LVEF=60% and with ventricular synchrony.
- Patients signed the written informed consent for the study
- Patients can endure the required follow up
Exclusion Criteria:
- Patients with atrial fibrillation
- Patients with atrial-ventricular block
- Patients with LBBB
- Patients with significant valvular disease
- Patients with severe hematopathy or severe renal inadequacy
- Patients with life expectancy < 1.5 year
- Patients who are in the period of pregnant or lactation
- Patients who are younger than 18 years old
- Patients who are ongoing other devices or agents study
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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Sinus-node Dysfunction
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Intervention(s)
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Device: Right ventricular lead location
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Primary Outcome(s)
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Left ventricular ejection fraction (LVEF)
[Time Frame: 18 months]
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Secondary Outcome(s)
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left ventricular end-systolic volume (LVESV)
[Time Frame: 18 months]
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Secondary ID(s)
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CR-10-016-AP-LV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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