Hidden heart rhythms: can monitoring reveal best treatment for blocked arteries?

NCT ID NCT04542460

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks heart rhythm problems in 200 people with a chronic total coronary occlusion (a completely blocked heart artery). All participants get a small implanted heart monitor (loop recorder) to detect dangerous arrhythmias. The goal is to compare how often these occur in patients treated with medication alone versus those who also undergo a procedure (PCI) to open the blockage. The study also looks at patients whose PCI was unsuccessful.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could clarify how often dangerous heart rhythms occur in CTO patients and whether PCI or medication better reduces that risk.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test a new therapy, and results may not change current care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aalborg university hospital

    Aalborg, North Denmark, 9000, Denmark