Heart Failure Clinical Trial
CRT Pilot Study for Children With Heart Failure
Summary
To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.
Eligibility Criteria
Inclusion Criteria:
Chronic and severe heart failure, NYHA class III or IV
Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
Chronic systemic ventricular dysfunction as defined in the protocol.
Intra ventricular conduction delay defined by spontaneous QRS duration > ULN for age.
All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
Signed and dated informed consent.
Able to receive pectoral or abdominal implant.
Exclusion criteria:
Suspected acute myocarditis.
Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
Acute coronary syndrome.
Adolescents who are pregnant.
Patient with BVP device implanted previously.
Patient has had prior/past heart transplantation.
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There is 1 Location for this study
Salt Lake City Utah, 84112, United States
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