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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: |
NCT00399594 |
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Date of registration:
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13/11/2006 |
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Primary sponsor: |
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Public title:
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Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
INCREMENTAL |
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Scientific title:
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Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL). |
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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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300 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00399594 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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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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Derek V Exner, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Libin Cardiovascular Institute of Alberta, University of Calgary |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- LV EF = 0.40 measured within 3 months of enrollment,
- SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity
limitation due to heart failure within 1 month of enrollment.
- Confirmed dyssynchrony on screening echo (1.1.9), &
- On stable doses of ACE inhibitor or angiotensin II blocker & a beta-blocker for = 2
months unless medically contra-indicated.
- Controlled heart rate if in permanent AF (resting <70 & maximal <120).
Exclusion Criteria:
- Unable or unwilling to provide informed consent,
- Medical condition other than heart failure likely to cause death < 1 year,
- Cardiac transplant planned within 6 months,
- Known contra-indication to transvenous CRT device implant (e.g., active sepsis,
artificial tricuspid valve, known vascular occlusion that will prevent delivery of
leads transvenously),
- Clinically significant myocardial infarction within last 2 months, or
- Coronary bypass graft surgery = 2 months or coronary angioplasty = 1 month
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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Cardiac Pacing, Artificial
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Defibrillators
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Heart Failure, Congestive
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Intervention(s)
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Procedure: A
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Procedure: B
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Primary Outcome(s)
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Change in end systolic volume plus reduction in symptoms
[Time Frame: over 12 months]
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Secondary Outcome(s)
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Hospitalization
[Time Frame: Study duration]
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LV volumes.
[Time Frame: Change over 12 months]
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Minnesota Living with Heart Failure score.
[Time Frame: Change over 12 months]
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Mortality
[Time Frame: Study duration]
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N-terminal pro-B-type natriuretic peptide.
[Time Frame: Change over 12 months]
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New York Heart Association class.
[Time Frame: Change over 12 months]
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Short form thirty six score.
[Time Frame: Change over 12 months]
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Six minute walk distance.
[Time Frame: Change over 12 months]
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Specific Activity Scale score.
[Time Frame: Change over 12 months]
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Secondary ID(s)
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CAH 70-3402
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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