Status:
COMPLETED
Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Medtronic
Conditions:
Heart Failure, Congestive
Cardiac Pacing, Artificial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Identifying \& optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death \& hospitalization. Car...
Detailed Description
Background. Identifying \& optimizing strategies to reduce the burden of heart failure (HF) is vital. Despite advances in pharmacotherapy, patients with HF are at high risk for death \& hospitalizatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00399594
Start Date
March 1 2011
End Date
November 1 2015
Last Update
November 24 2015
Active Locations (3)
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1
Foothills Hospital
Calgary, Alberta, Canada, T2N4N1
2
London Health Sciences
London, Ontario, Canada
3
Quebec Heart Institute
Ste-Foy, Quebec, Canada, G1V4G5