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ACTIVE NOT RECRUITING
NCT04542460
NA

The Nordic Baltic Chronic Total Occlusion (CTO) Arrhythmia Study

Sponsor: Leif Thuesen

View on ClinicalTrials.gov

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.

Official title: Chronic Total Coronary Occlusion; Arrhythmia in Patients With Adjunction of PCI to Optimal Medical Treatment Versus Optimal Medical Treatment and in Patients With Failed PCI.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-11-01

Completion Date

2027-09-01

Last Updated

2026-03-20

Healthy Volunteers

No

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.

Locations (1)

Aalborg university hospital

Aalborg, North Denmark, Denmark