Specialized Pacing for Patients With Congenital Heart Disease (NCT03361189) | Clinical Trial Compass
TerminatedPhase 2/3
Specialized Pacing for Patients With Congenital Heart Disease
Stopped: Insufficient recruitment
United States4 participantsStarted 2021-05-09
Plain-language 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.
Who can participate
Age range
14 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Blunted or Unchanged Effect of Mental Stress on Heart Rate
Timeframe: 3 months after the start of each intervention, a total of 6 months
2
Heart Rate Response During a 48-hour Assessment Period
Timeframe: 3 months after the start of each intervention, a total of 6 months