Incidence of ventricular arrhythmias in patients with chronic total coronary occlusion recanalizatio

Completed

Conditions: Chronic total occlusion of the coronary arteries
Ventricular arrhythmias
10011082

Registration Number: NL-OMON55852

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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:, a) 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., b) 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., c) 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 ILR.

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
(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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the incidence of ventricular arrhythmias in patients with successful<br /><br>CTO recanalization, failed CTO recanalization, and untreated CTO during a<br /><br>follow-up period of 3 years. Ventricular arrhythmias will be defined as<br /><br>sustained ventricular tachycardia >30 s or ventricular fibrillation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To assess the occurrence of all-cause mortality<br /><br>• To assess the occurrence of cardiovascular death<br /><br>• To assess the occurrence of major adverse cardiac events (MACE). MACE include<br /><br>myocardial infarction, urgent revascularization, stroke, or death.</p><br>