Back to resultsIncidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization (VACTOR)
Primary Purpose
Chronic Total Occlusion of Coronary Artery
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Total Occlusion of Coronary Artery focused on measuring Chronic Total Occlusion of Coronary Artery, Ventricular Arrythmia, Sustained VT, Ventricular Fibrillation, Implantable loop recorder
Eligibility Criteria
Inclusion criteria:
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:
- 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.
- 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.
- Untreated CTO diagnosed in the previous 6 months.
- Age ≥18 years.
- Written informed consent.
- Patient agrees to the follow-up including the implantation of the ICM.
Exclusion Criteria:
- Patients who are potential candidates for an ICD according to the 2015 ESC guidelines.
- Patients who have a cardiac implantable electrical device (CIED) (e.g., pacemaker, ICD).
- Patient has reduced immune function or is otherwise at high risk for infection.
- Patient has had a recent (within 30 days) or otherwise unresolved infection.
- Known pregnancy at time of inclusion.
- 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).
Sites / Locations
- Erasmus Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Patients who have undergone a successful percutaneous CTO recanalization
Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO
Outcomes
Primary Outcome Measures
Ventricular Arrhythmias
Sustained ventricular tachycardia (>30 s) or ventricular fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT03475888
First Posted
March 12, 2018
Last Updated
May 21, 2023
Sponsor
Erasmus Medical Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03475888
Brief Title
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
Acronym
VACTOR
Official Title
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Total Occlusion of Coronary Artery
Keywords
Chronic Total Occlusion of Coronary Artery, Ventricular Arrythmia, Sustained VT, Ventricular Fibrillation, Implantable loop recorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center pilot study of patients with CTO.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients who have undergone a successful percutaneous CTO recanalization
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO
Intervention Type
Device
Intervention Name(s)
Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)
Intervention Description
Implantation of Medtronic Reveal LINQ™ ICM
Primary Outcome Measure Information:
Title
Ventricular Arrhythmias
Description
Sustained ventricular tachycardia (>30 s) or ventricular fibrillation
Time Frame
3 years after ICM implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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:
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.
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.
Untreated CTO diagnosed in the previous 6 months.
Age ≥18 years.
Written informed consent.
Patient agrees to the follow-up including the implantation of the ICM.
Exclusion Criteria:
Patients who are potential candidates for an ICD according to the 2015 ESC guidelines.
Patients who have a cardiac implantable electrical device (CIED) (e.g., pacemaker, ICD).
Patient has reduced immune function or is otherwise at high risk for infection.
Patient has had a recent (within 30 days) or otherwise unresolved infection.
Known pregnancy at time of inclusion.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sing-Chien Yap, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
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