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| Descriptive Information Fields | |||||||||
| Brief Title † | Right Apical Versus Septal Pacing Trial | ||||||||
| Official Title † | Right Apical Versus Septal Pacing Trial | ||||||||
| Brief Summary | The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing. |
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| Detailed Description | The primary objective of this study is to compare the effect of RV pacing site on LV systolic function as measured by LVEF (left ventricular ejection fraction). Secondary objectives of this trial include:
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | LV ejection fraction measured by radionuclide ventriculography (RVG). | ||||||||
| Secondary Outcome Measure † | 1. left ventricular diastolic and systolic function indices 2-D echocardiogram/Doppler (ECHO/DOPP) 2. all cause mortality 3.non-fatal thromboembolic events including stroke 4.heart failure hospitalization or intravenous drug therapy in an outpatient heart failure clinic 5.occurrence of new-onset atrial fibrillation or progression to permanent atrial fibrillation 6. symptoms and quality of life scores (DUke Activity Status Index, short form (SF)-12 scores 7. NYHA class using SAS survey, 6 minute hall walk distance 8. serum brain natriuretic peptide level (BNP), which has been shown to be elevated in ventricular paced patients 9. lead-related complications such as lead dislodgement, myocardial perforation, lead integrity failure, high pacing threshold 10. total implant procedure and flouroscopy time |
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| Condition † | Heart Block Heart Failure |
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| Intervention † | Device: Permanent Pacemaker Implantation | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 160 | ||||||||
| Start Date † | April 2005 | ||||||||
| Completion Date | December 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Canada | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00199498 | ||||||||
| Organization ID | RASP | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Lawson Health Research Institute | ||||||||
| Collaborators †† | Medtronic | ||||||||
| Investigators † |
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| Information Provided By | Lawson Health Research Institute | ||||||||
| Verification Date | September 2005 | ||||||||
| First Received Date † | September 13, 2005 | ||||||||
| Last Updated Date | September 13, 2005 | ||||||||