Status:
UNKNOWN
Quadripolar Leads for the Management of Heart Failure Patients in the Middle East
Lead Sponsor:
King Abdullah International Medical Research Center
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Heart failure is the most rapidly growing cardiovascular condition in developed countries. Despite advances in medical therapy, patients with heart failure are at high risk for death and hospitalizati...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years of age
- Patient met standard CRT-D device indications (Left Ventricular Ejection Fraction (LVEF) ≤ 35%, QRS ≥ 120 ms, New York Heart Association (NYHA) Class II, III or ambulatory Class IV Heart Failure (HF) symptoms with optimal recommended medical therapy) and will be implanted with an St Jude Medical CRT-D
- Patient is willing to provide written informed consent.
Exclusion
- Patient with non left bundle branch block (RBBB, intraventricular delay (IVCD) Block)
- Patient has an epicardial ventricular lead system.
- Patient has limited intrinsic atrial activity (≤ 40 bpm).
- Patient has persistent or permanent Atrial Fibrillation.
- Patient's life expectancy is less than 1 year
- Patient is pregnant.
- Patient is dependent on IV inotropic agents.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT02195843
Start Date
August 1 2014
End Date
August 1 2016
Last Update
July 21 2014
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