The primary objective of the study is to explore the possibilities measurement of STV-ARI on human intracardiac signals, to compare this with the STV-QT on the surface ECG during sinus rhythm and while pacing the heart with different frequencies.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Short-term variability of repolarization (STV) of 30 consecutive beats is
measured from different recording sites (ECG, RV EGM, LV EGM, unipolar &
bipolar signals). STV is claculated with the formula *|D(n+1)-Dn |/30×*2,
where D represents the repolarization duration and n the number of complexes,
in this case 30 complexes. The repolarization duration is defined and measured
differently per recording site. All intracardiac and ECG leads can be recorded
simultaneously.
- STV-QT: QT-interval is defined as the interval from the beginning of the
Q-wave until the end of the T-wave.
- STV-ARI: repolarization duration is defined as the interval from the minimal
dV/dt of the QRS complex to the maximum or minimum dV/dt of the T wave,
depending on the morphology of the T-wave.
Secondary outcome
-- Age at implantation;
- Sex;
- Left ventricular ejection fraction (LVEF) measured by MRI, nuclear imaging or
echocardiography;
- NYHA class;
- Underlying cardiac disease (ischemic cardiomyopathy, dilated cardiomyopathy,
other);
- Cardiovascular risk factors( smoking, hypertension, diabetes mellitus,
peripheral artery disease, COPD)
- Relevant comorbidities (COPD, chronic kidney disease, malignancy)
- Medications (beta blockers, ACE-inhibitors/AT2-antagonists, aldosterone
antagonists, diuretics, calcium blockers, digoxin, class I or III
anti-arrhythmic drugs)
- ECG parameters (RR-interval, PQ-interval, QRS-duration, QRS-morphology,
RV-pacing: yes/no)
Background summary
Sudden cardiac death (SCD) caused by ventricular tachyarrhythmias, such as
sustained ventricular tachycardia (VT) and ventricular fibrillation (VF)
remains an important health problem in the Western world. Multiple randomized
controlled trials, like MADIT II or SCD-HeFT, have demonstrated a survival
benefit of implantation of an implantable-cardioverter defibrillator (ICD) in
patients with a reduced left ventricular ejection fraction (LVEF) who are at
high risk of developing ventricular arrhythmias. Since these landmark trials,
ICD implantation has become a class I recommendation in international
guidelines for patients with reduced LVEF below 35% due to ischemic and
non-ischemic cardiomyopathy. Nevertheless, while ICD-therapy as
anti-tachycardia pacing and shocks, are highly effective in prevention of SCD
by termination of sustained arrhythmias, they do not prevent VT/VF from
occurring. Additional treatment, such as anti-arrhythmic drugs or
radiofrequency (RF) ablation, are often used as adjunctive therapy to reduce
the number of ICD-shocks.
It would therefore be more effective if the device could detect if arrhythmias
are impending and initiate pacing therapy to prevent the arrhythmia and thus
the ICD-shock from occurring. This requires continuous monitoring of the
arrhythmogenic potential of the patient to alert the device when a patient
becomes highly susceptible to ventricular arrhythmias.
In an arrhythmogenic animal model it has been shown that beat-to-beat
variability, measured as short-term variability (STV) of the activation
recovery interval or ARI of the intracardiac EGM, increases abruptly prior to
occurrence of arrhythmias. In this study we want to explore the potential of
STV-ARI measurements on human intracardiac signals.
Study objective
The primary objective of the study is to explore the possibilities measurement
of STV-ARI on human intracardiac signals, to compare this with the STV-QT on
the surface ECG during sinus rhythm and while pacing the heart with different
frequencies.
Study design
This study will be a cross-sectional, non-invasive, observational study with
one time point of observation. The study will be performed in patients that are
scheduled for ICD implantation at the UMC Utrecht, with a lead in the right
atrium and the right ventricle. During the implantation procedure, additional
measurements will be performed, for which no additional invasive procedures are
needed. No additional follow-up or tests have to be scheduled.
Study burden and risks
The measurements will add approximately 15 minutes extra time to the duration
of the procedure but will not lead additional risk of harm or discomfort to the
patient. The only (minor) risks present in the current study are related to the
implantation itself which follows standard procedures.
Yalelaan 50
Utrecht 3584 CM
NL
Yalelaan 50
Utrecht 3584 CM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must have an
indication for an ICD according to ESC guidelines published in 2016:
- Secondary prophylaxis for sudden cardiac death (SCD) and ventricular
tachycardia (VT), - Primary prophylaxis for SCD and VT
- Left ventricular ejection fraction (LVEF) <35% and New York Heart
Association (NYHA) functional class II, III, despite adequate
medical therapy.
- LVEF <30% and NYHA class I, despite adequate medical therapy, - A dual
chamber system with a lead in the right atrium (RA) and the right ventricle (RV)
- Elective replacement of the device (for example due to battery depletion)
- Sinus rhythm at implantation
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Age < 18 years
- QRS-duration >120 ms
- Contra-indications for ICD-implantation
- Permanent atrial fibrillation
- Atrioventricular block, 2nd and 3rd degree
Design
Recruitment
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 |
|---|---|
| CCMO | NL62580.041.17 |