Specialized Pacing for Patients With Congenital Heart Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03361189 |
Recruitment Status :
Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : April 23, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Heart Disease Bradycardia Sinus | Device: Closed loop stimulation | Phase 2 Phase 3 |

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, 2020 |
Estimated Primary Completion Date : | February 1, 2023 |
Estimated Study Completion Date : | August 1, 2023 |

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).
|
- Heart rate response [ Time Frame: 3 months ]Heart rate in response to mental stress and autonomic input will be asssessed
- Oxygen uptake [ Time Frame: 3 months ]Oxygen uptake will be determined by cardiopulmonary gas exchange
- Quality of life [ Time Frame: 3 months ]Quality of life will be assessed by SF-36 questionnaire

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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%

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
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 |
United States, California | |
University of California at Los Angeles | |
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 |
Responsible Party: | Jeremy P. Moore, MD, Associate Professor of Pediatrics, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT03361189 |
Other Study ID Numbers: |
17-000932 |
First Posted: | December 4, 2017 Key Record Dates |
Last Update Posted: | April 23, 2019 |
Last Verified: | April 2019 |
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 |
Product Manufactured in and Exported from the U.S.: | No |
Congenital heart disease Pacemaker Sinus node dysfunction |
Heart Diseases Heart Defects, Congenital Bradycardia Cardiovascular Diseases |
Cardiovascular Abnormalities Congenital Abnormalities Arrhythmias, Cardiac Pathologic Processes |