Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy
Paragon Pacemaker
Aortic Valve Disease+5
+ Aortic Stenosis, Subvalvular
+ Aortic Valve Stenosis
Treatment Study
Summary
Study start date: October 6, 1993
Actual date on which the first participant was enrolled.Several studies have shown that dual chamber (DDD) pacemaker therapy relieves LV outflow obstruction and improves symptoms in most adult patients with obstructive hypertrophic cardiomyopathy (HCM). It is however, uncertain whether DDD pacing will be efficacious in children with obstructive HCM, because of evolving cardiac morphology and increased LV hypertrophy and outflow obstruction associated with rapid body growth. We propose to monitor clinical progress, and cardiac morphologic and hemodynamic changes over several years following implantation of a DDD pacemaker in children who present with obstructive HCM between the ages of 5 to 15 years. Functional status, myocardial ischemia, arrhythmias, and LV outflow obstruction will be evaluated by exercise tests, echocardiography, thallium scintigraphy, Holter monitoring, electrophysiologic and cardiac catheterization studies. The results of pacemaker therapy will be compared with the findings in a cohort of young patients with obstructive HCM who elect not to be treated with DDD pacemaker.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 5 to 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: DDD Pacemaker Therapy Children of either gender, aged 5 to 15 years. Presence of LV hypertrophy and LV outflow obstruction. EXCLUSION CRITERIA: DDD Pacemaker Therapy Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization. Chronic atrial fibrillation. Positive pregnancy test. INCLUSION CRITERIA: Cohort Study Children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data). Presence of LV hypertrophy and LV obstruction. EXCLUSION CRITERIA: Cohort Study Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization. Chronic atrial fibrillation. Positive pregnancy test.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps