Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Dundee.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Dundee
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01055210
First received: January 22, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | January 22, 2010 | ||||
| Last Updated Date | January 22, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
6 minute hall walk test [ Time Frame: 4 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Echocardiographic measures of desynchrony [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study | ||||
| Official Title ICMJE | Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study | ||||
| Brief Summary | An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Optimisation of VV delay
Programmed VV delay altered on device |
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| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | February 2011 | ||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01055210 | ||||
| Other Study ID Numbers ICMJE | ELD002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Anna Maria Choy, University of Dundee | ||||
| Study Sponsor ICMJE | University of Dundee | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Dundee | ||||
| Verification Date | January 2010 | ||||
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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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