The Nordic Baltic Chronic Total Occlusion (CTO) Arrhythmia Study

NCT04542460 | Active Not Recruiting DMC

• 1 other identifier: CTO-ARRHYTHMIA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of clinically significant arrhythmias

  Rate og clinically significant arrhythmias in PCI versus medically only treated patients by loop recorder (table 1) and in patients with failed PCI.

  1 year

Study Arms (2)

Optimal Medical Treatment

NO INTERVENTION

CTO patients receiving optimal medical treatment

Optimal Medical Treatment and PCI

ACTIVE COMPARATOR

CTO patients receiving PCI in ajunction to optimal medical treatment

Procedure: PCI

Interventions

PCI PROCEDURE

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.

Also known as: Loop recorder

Optimal Medical Treatment and PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leif Thuesen: lead

Study Sites (1)

Aalborg university hospital

Aalborg, North Denmark, 9000, Denmark

Location

Study Officials

• Peter Soegaard, DMSc

  Co-PI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of PCI Research

Model Details: Investigator conceived, initiated and driven 1:1 randomized open label clinical trial

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 9, 2020
• Study Start: November 1, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)