Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization

Not Applicable

Completed

• Conditions: Chronic Total Occlusion of Coronary Artery
• Interventions: Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)

• Registration Number: NCT03475888
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-23
• Study Start: 2018-09-28
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who are potential candidates for an ICD according to the 2015 ESC guidelines.
2. Patients who have a cardiac implantable electrical device (CIED) (e.g., pacemaker, ICD).
3. Patient has reduced immune function or is otherwise at high risk for infection.
4. Patient has had a recent (within 30 days) or otherwise unresolved infection.
5. Known pregnancy at time of inclusion.
6. Patient has severe co-morbidity that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)	Patients who have undergone a successful percutaneous CTO recanalization
Group B	Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)	Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO

Primary Outcome Measures

Name	Time	Method
Ventricular Arrhythmias	3 years after ICM implantation	Sustained ventricular tachycardia (\>30 s) or ventricular fibrillation

Trial Locations

Locations (2)

VUMC; 🇳🇱 Amsterdam, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands