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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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17 October 2012 |
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Main ID: |
NCT00964938 |
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Date of registration:
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25/05/2009 |
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Primary sponsor: |
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Public title:
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Multisite Pacing With a Quadripolar Lead
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Scientific title:
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Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00964938 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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Canada
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Contacts
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Name:
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B Thibault |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montreal Heart |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have a scheduled CRT implantation at the participating clinical study site
- Have NYHA functional class III or IV, ejection fraction less than or equal to 35%,
and QRS duration greater than 120ms
- Be undergoing a new St. Jude Medical CRT-D device system (including LV lead)
implantation
- Have the ability to provide informed consent for study participation and be willing
and able to comply with the prescribed perioperative evaluations
Exclusion Criteria:
- Have persistent or permanent atrial fibrillation
- Have an intrinsic heart rate of <50 beats per minute
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3
months prior to enrollment or be scheduled for such procedures
- Have had a recent CVA or TIA within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
- Have ischemic etiology and are unable to tolerate stress echocardiography
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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Heart Failure
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Intervention(s)
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Device: Quadripolar LV lead (pacing configurations)
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Primary Outcome(s)
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dP/dt max
[Time Frame: acute: during implant procedure; 1 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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