Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization (VACTOR)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VUMC
  • Rotterdam, Netherlands
    • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Presence of CTO defined as complete obstruction of the vessel with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 and an estimated duration of ≥3 months, and one of the following:

   1. A successful percutaneous CTO recanalization for stable angina within the previous 6 months. A successful CTO recanalization is defined as a final TIMI flow grade ≥2 and a residual stenosis ≤30% after stent implantation.
   2. A failed percutaneous CTO recanalization for stable angina within the previous 6 months. A failed CTO recanalization is defined as not fulfilling the criteria for successful CTO recanalization.
   3. Untreated CTO diagnosed in the previous 6 months.
2. Age ≥18 years.
3. Written informed consent.
4. Patient agrees to the follow-up including the implantation of the ICM.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients who have undergone a successful percutaneous CTO recanalization	Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM); Implantation of Medtronic Reveal LINQ™ ICM
Active Comparator: Group B; Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO	Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM); Implantation of Medtronic Reveal LINQ™ ICM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular Arrhythmias	Sustained ventricular tachycardia (>30 s) or ventricular fibrillation	3 years after ICM implantation

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Sing-Chien Yap, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• Assaf A, Sakhi R, Diletti R, Hirsch A, Allaart CP, Bhagwandien R, Firouzi M, Smits PC, Hoogendijk MG, Theuns DAMJ, Yap SC. Incidence of ventricular arrhythmias in patients with chronic total coronary occlusion: Results of the VACTOR study. Int J Cardiol Heart Vasc. 2023 Dec 18;50:101323. doi: 10.1016/j.ijcha.2023.101323. eCollection 2024 Feb.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Implantable loop recorder; Ventricular Fibrillation; Chronic Total Occlusion of Coronary Artery; Ventricular Arrythmia; Sustained VT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: NL59827.078.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No