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Specialized Pacing for Patients With Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT03361189
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Jeremy P. Moore, MD, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Bradycardia Sinus Device: Closed loop stimulation Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Patient Enrollment: The treating physician will identify potential subjects with a previously implanted pacemaker and present a brief overview of the study. Informed consent will be obtained by the investigator after discussing the study, including the voluntary nature of participation and notification the subject can withdraw at any time. The investigator will give the subject and his/her legal guardian the opportunity to take the consent home to think about it more, with the option to call or meet with the investigator to ask additional questions. If the subject and/or his/her parent/legal guardian agree to participate, the investigator will ask them to sign a written, informed consent and assent.

Randomization Procedure: This will be a single-blind placebo-controlled randomized crossover study with 2 treatments: CLS-on versus CLS-off (accelerometer only). Each enrolled patient will receive both treatments for 3 months. The order of treatments will be randomized 1:1.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Closed Loop Stimulation After Epicardial Pacemaker Implantation for Congenital Heart Disease
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: CLS-On
Subjects in this arm will programmed to CLS-on to received closed loop stimulation-based pacing.
 Device: Closed loop stimulation
Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
No Intervention: CLS-Off
Subjects in this arm, will be placed in a standard pacing mode (i.e. AAIR or DDDR).


Outcome Measures
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Primary Outcome Measures :
  1. Heart rate response [ Time Frame: 3 months ]
    Heart rate in response to mental stress and autonomic input will be asssessed


Secondary Outcome Measures :
  1. Oxygen uptake [ Time Frame: 3 months ]
    Oxygen uptake will be determined by cardiopulmonary gas exchange

  2. Quality of life [ Time Frame: 3 months ]
    Quality of life will be assessed by SF-36 questionnaire


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361189


Contacts
Contact: Jeremy P Moore, MD, MS 310-267-7600 jpmoore@mednet.ucla.edu
Contact: Kevin M Shannon, MD 310-267-7600 kshannon@mednet.ucla.edu

Locations
United States, California
University of California at Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Jeremy P Moore, MD, MS    310-267-7600    jpmoore@mednet.ucla.edu   
Contact: Kevin M Shannon, MD    310-267-7600    kshannon@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Biotronik, Inc.
More Information
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Publications of Results:

Responsible Party: Jeremy P. Moore, MD, Associate Professor of Pediatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03361189     History of Changes
Other Study ID Numbers: 17-000932
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jeremy P. Moore, MD, University of California, Los Angeles:
Congenital heart disease
Pacemaker
Sinus node dysfunction

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Bradycardia
Cardiovascular Diseases
 Cardiovascular Abnormalities
Congenital Abnormalities
Arrhythmias, Cardiac
Pathologic Processes