The objective of the present pilot study is to assess the incidence of sustained VA in 3 CTO groups: patients with successful percutaneous CTO recanalization (group A), patients with failed percutaneous CTO recanalization (group B), and patients…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the incidence of ventricular arrhythmias in patients with successful
CTO recanalization, failed CTO recanalization, and untreated CTO during a
follow-up period of 3 years. Ventricular arrhythmias will be defined as
sustained ventricular tachycardia >30 s or ventricular fibrillation.
Secondary outcome
• To assess the occurrence of all-cause mortality
• To assess the occurrence of cardiovascular death
• To assess the occurrence of major adverse cardiac events (MACE). MACE include
myocardial infarction, urgent revascularization, stroke, or death.
Background summary
Chronic total occlusion (CTO) is a common condition among patients with
coronary artery disease, with a reported prevalence between 20% to 50% in
patients with ischemia referred to the catheterization laboratory.1,2
Successful CTO recanalization has been associated with improved long-term
survival in several non-randomized studies.3-10 A recent single-center study
demonstrated that all-cause mortality was 17.2% for unsuccessful CTO
recanalization and 4.5% for successful CTO recanalization at 5 years of
follow-up.3 Interestingly, only a minority (7%) of the unsuccessful CTO
recanalization population had a left ventricular ejection fraction (LVEF) <40%.
There is limited data on the cause of death in this specific population.
Study objective
The objective of the present pilot study is to assess the incidence of
sustained VA in 3 CTO groups: patients with successful percutaneous CTO
recanalization (group A), patients with failed percutaneous CTO recanalization
(group B), and patients with untreated CTO (group C).
Study design
Three-arm pilot study of patients with CTO.
A. patients who have undergone a successful percutaneous CTO recanalization;
B. patients who have undergone a failed percutaneous CTO recanalization;
C. patients with an untreated CTO
An ILR will be implanted to continuously monitor heart rate and rhythm during
the follow-up period. There will be one extra outpatient clinic visit at 10
days after the procedure to inspect the wound. Every patient will have regular
follow-up visits according to the local practice until battery depletion of the
device (standard of care). The expected device longevity is approximately 3
years.
Study burden and risks
Patients will receive an ILR which is a small device that is placed
subcutaneously using local anesthetics. The procedure will take approximately
10 minutes. There will be one extra outpatient clinic visit at 10 days after
the procedure to inspect the wound. Every patient will have regular follow-up
visits according to the local practice until battery depletion of the device
(standard of care). The expected device longevity is approximately 3 years.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03475888 |
| CCMO | NL59827.078.16 |