Status:
TERMINATED
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Lead Sponsor:
Duke University
Collaborating Sponsors:
American Heart Association
Conditions:
Heart Failure
Right Bundle-Branch Block
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic pro...
Eligibility Criteria
Inclusion
- Cardiomyopathy of either idiopathic or ischemic etiology
- NYHA class III, or IV symptoms
- Sinus rhythm
- QRS complex duration \> 130 msec in ≥ 2 surface ECG leads with RBBB
- PR interval \> 150 msec and \< 240 msec
- Prior implantation of dual chamber BiV ICD with apical RV lead location
Exclusion
- Myocardial infarction, major surgical procedure, or acute cardiac failure crisis requiring inotropes within 6 months of entry into the study
- Atrial fibrillation or flutter lasting \>12 hours within the last 6 months
- Sick sinus syndrome, complete heart block, or other arrhythmias requiring pacemaker support
- Pregnancy
- Any other known condition other than heart failure that could limit exercise time or survival to \< 6 months
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01169493
Start Date
January 1 2011
End Date
August 1 2014
Last Update
September 23 2016
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Durham VA Medical Center
Durham, North Carolina, United States, 27710