The Nordic Baltic Chronic Total Occlusion (CTO) Arrhythmia Study (NCT04542460) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Nordic Baltic Chronic Total Occlusion (CTO) Arrhythmia Study
Denmark200 participantsStarted 2020-11-01
Plain-language summary
In patients with a chronic total coronary occlusion (CTO ), clinically significant arrhythmia seems to be an important and a poorly investigated problem. The arrhythmia prevalence in an all-comer CTO-population is unknown, but in ICD-populations with ischemic heart disease, a CTO may be found in half of patients with life-threatening arrhythmia.The purpose of the CTO-ARRHYTHMIA study, is to investigate the incidence of clinically significant arrhythmias in CTO patients using an implantable loop recorder. Further, the investigators intend to identify predictors for arrhythmias as well as the impact on arrhythmia of optimized pharmacological treatment and revascularization in CTO patients.
Who can participate
Age range
18 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:
* ≥1 CTO lesion amenable to PCI.
* Stable or stabilized coronary artery disease.
* Angiographic/echocardiographic signs of reversible perfusion.
* CTO lesion in a coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).
Exclusion Criteria:
* Expected survival \<1 year.
* Patients with an indication of ICD due to EF \< 35 or previous ventricular tachycardia.
* Patients with a cardiac device i.e. ICD, pacemaker or cardiac resynchronizing treatment device.
* Renal failure on dialysis.
* Lesions treated with PCI within one month.
* Indication for coronary artery bypass grafting (CABG). I.e. Two-or three vessel disease or left main disease and a syntax score \>22.
* Significant valvular heart disease.
* Declined informed consent.
* Regarding CMRI: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants.
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.