Status:
COMPLETED
Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Chronic Total Occlusion of Coronary Artery
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03475888
Start Date
September 28 2018
End Date
December 12 2022
Last Update
February 20 2024
Active Locations (2)
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1
VUMC
Amsterdam, Netherlands
2
Erasmus Medical Center
Rotterdam, Netherlands