Chronic Total Occlusion of Coronary ArteryVACTORNCT03475888
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
A study testing Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) in people with Chronic Total Occlusion of Coronary Artery, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesNetherlands
- Study dates
- 28 Sep 2018to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Being tested
- Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)
- Keywords
- Chronic Total Occlusion of Coronary Artery, Ventricular Arrythmia, Sustained VT, Ventricular Fibrillation, Implantable loop recorder
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)Device
Implantation of Medtronic Reveal LINQ™ ICM
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients who have undergone a successful percutaneous CTO recanalization Receives: Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) |
| Group B | Active comparator | Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO Receives: Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Arrhythmias
Sustained ventricular tachycardia (>30 s) or ventricular fibrillation
Measured: 3 years after ICM implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start28 Sep 2018
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single center pilot study of patients with CTO.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Sing-Chien Yap, MD, PhD, Erasmus Medical Center
- Investigators
- Sing-Chien Yap, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475888
- Sponsor's protocol ID
- NL59827.078.16
- Acronym
- VACTOR
- Status last verified
- Feb 2024
- First submitted
- 12 Mar 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38188347
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
- ClinicalTrials.gov ID
- NCT03475888
- Acronym / sponsor ID
- VACTOR / NL59827.078.16
- Keywords
- Chronic Total Occlusion of Coronary Artery, Ventricular Arrythmia, Sustained VT, Ventricular Fibrillation, Implantable loop recorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center pilot study of patients with CTO.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)Patients who have undergone a successful percutaneous CTO recanalization |
| Group B | Active comparator | Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Age ≥18 years.
- Written informed consent.
- Patient agrees to the follow-up including the implantation of the ICM.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)Implantation of Medtronic Reveal LINQ™ ICM | Device | Group A, Group B |
Primary outcome
Ventricular Arrhythmias
Time frame: 3 years after ICM implantation
Sustained ventricular tachycardia (>30 s) or ventricular fibrillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 38188347Assaf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sing-Chien Yap, MD, PhD principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) in people with Chronic Total Occlusion of Coronary Artery, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular Arrhythmias (time frame: 3 years after ICM implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.