Status:
TERMINATED
Specialized Pacing for Patients With Congenital Heart Disease
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Biotronik, Inc.
Conditions:
Congenital Heart Disease
Bradycardia Sinus
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Sinus node dysfunction is highly prevalent among patients with congenital heart disease, manifesting as resting bradycardia or chronotropic incompetence. As children and adults with congenital heart d...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
May 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03361189
Start Date
May 9 2021
End Date
November 3 2021
Last Update
January 20 2023
Active Locations (1)
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1
University of California at Los Angeles
Los Angeles, California, United States, 90095