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Specialized Pacing for Patients With Congenital Heart Disease

About

Brief Summary

The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing algorithm has been shown to be highly effective for a wide range of clinical scenarios. Despite the fact that congenital heart disease (CHD) patients are likely to derive significant benefit in terms of functional ability and aerobic capacity using this novel technology, the CLS system has not been adequately studied in this population. As many CHD patients also undergo epicardial placement of pacing systems at the time of concomitant cardiac surgery, CLS has been less often utilized in this population given almost no data in the setting of surgical electrode placement. The present study intends to examine the benefits of the CLS algorithm in the CHD population, employing the use of epicardial pacemaker systems in the study protocol.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2/Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
14 Years
Maximum Age
65 Years

Inclusion Criteria:

  • Congenital heart disease
    • Simple, moderate, or complex congenital heart disease
  • Adolescent or adult age group (age >14 and <65 years)
  • Significant sinus node dysfunction
    • Atrial pacing percentage >70%11
    • Intrinsic dysfunction resulting from congenital lesion or cardiac surgery
    • Secondary sinus node dysfunction due to antiarrhythmic drug therapy
  • Existing, fully functional pacemaker or ICD with CLS capability
  • Epicardial or transvenous route of pacemaker implantation

Exclusion Criteria:

  • Unable to complete cardiopulmonary exercise testing (CPET)
  • Contraindication to CPET
  • Decreased mental capacity or known psychiatric disorder
  • Congestive heart failure, NYHA cass IV
  • Total atrial tachyarrhythmia burden >20%

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Study Stats
Protocol No.
17-000932
Category
Pediatrics
Contact
ROBYNN GOLDSTEIN
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03361189
For detailed technical eligibility, visit ClinicalTrials.gov.