Role of Left Ventricular Pacing Site
Recruitment status was Recruiting
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | June 28, 2007 | ||||||||
| Start Date ICMJE | November 2003 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Variation in left ventricular dp/dt max | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00221780 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Role of Left Ventricular Pacing Site | ||||||||
| Official Title ICMJE | Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure | ||||||||
| Brief Summary | Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed. |
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| Detailed Description | Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order. Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed. Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure Outcomes. Hemodynamic measures using pressure-volume catheters. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: left ventricular pacing | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 33 | ||||||||
| Estimated Completion Date | December 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00221780 | ||||||||
| Other Study ID Numbers ICMJE | 9426-01, 2001-030 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE | Ministry of Health, France | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Bordeaux | ||||||||
| Verification Date | June 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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