NCT03475888

Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A chronic total occlusion (CTO) is common in patients with coronary artery disease. CTO recanalization has been shown to improve survival in comparison to failed CTO recanalization. Whether this is related to ventricular arrhythmias (VA) is unknown. The purpose of this pilot study is to evaluate the incidence of VA after successful CTO recanalization and in those with failed CTO recanalization or untreated CTO. Patients will be monitored using an insertable cardiac monitor.

Detailed description

Rationale: Successful chronic total occlusion (CTO) recanalization has been associated with improved long-term survival. Furthermore, CTO is an independent predictor for the occurrence of ventricular arrhythmias (VA) in patients with ischemic cardiomyopathy and implantable cardioverter defibrillators (ICDs). One may speculate that a successful CTO recanalization may provide electrical stability. However, no data are available on the incidence of sustained VA in this patient population. Objective: The objective of the present pilot study is to assess the incidence of sustained VA in 2 CTO groups: patients with successful percutaneous CTO recanalization (group A), patients with failed percutaneous CTO recanalization or untreated CTO (group B). Study design: Pilot study of patients with CTO. Study population: A total of 90 patients will be enrolled with a maximum of 45 patients in each arm. Intervention: A Medtronic Reveal LINQ™ Insertable cardiac monitor (ICM) will be implanted in every patient to continuously monitor heart rhythm during the follow-up period. Main study parameters/endpoints: To assess the incidence of VA defined as sustained ventricular tachycardia \>30 s or ventricular fibrillation.

Conditions

• Chronic Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
DEVICE	Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)	Implantation of Medtronic Reveal LINQ™ ICM

Timeline

• Start date: 2018-09-28
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2018-03-23
• Last updated: 2024-02-20

Locations

2 sites across 1 country: Netherlands