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The Nordic Baltic Chronic Total Occlusion (CTO) Arrhythmia Study

NCT04542460 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Chronic Total Coronary Occlusion

Interventions

PROCEDURE

PCI

A loop recorder is implanted i all patients in both study groups to investigate: * Prevalence and severity of cardiac arrhythmias. * Effect on detected arrhythmia, in particular ventricular tachyarrhythmia, of optimal medical therapy vs. coronary revascularization by PCI. * Prevalence and severity of cardiac arrhythmias in CTO-patients with failed PCI. * Indication for prophylactic ICD implantation in CTO-patients treated conservatively or by PCI and after failed PCI. * Relation of arrhythmias to angina pectoris symptoms (CCS class), Quality of life questionnaire results and presence of myocardial reversible perfusion defects by CMRI.

Sponsors & Collaborators

  • Leif Thuesen

    lead OTHER

Principal Investigators

  • Peter Soegaard, DMSc · Co-PI

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2025-10-01
Completion
2027-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542460 on ClinicalTrials.gov