CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Paragon Pacemakerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00001396
NCT00001396Phase 1Completed

Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Nov 4, 1999·Updated Jul 2, 2017

In Brief

A Phase 1 clinical trial evaluating Paragon Pacemaker for Hypertrophic Cardiomyopathy. Completed, across 1 site.

Detailed Summary

Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of HCM in children. However, growth of the body and organs, including the heart, is very rapid during childhood. Therefore the long-term effects of DDD pacing in children are unknown. The purpose of this study is to examine the growth rate and nutrition of children with HCM. Due to this heart condition and the restrictions that are often placed on the child's activity level, children with HCM may grow at a slower rat and may have a greater tendency to be overweight. Children participating in the study will have their growth rate and nutritional status measured before the study begins and throughout the course of the study. Findings in this research study will not directly benefit the patients participating in it. However, information gathered as a result of this study may lead to improvements in the management of children with HCM in the future.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartOct 6, 1993
Study CompletionJul 23, 2008
TodayJul 2, 2026
Posted 26.7 years ago

Interventions

Paragon Pacemakerdevice