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Measurement of Short-term Variability of Activation-Recovery Interval on Human Intracardiac Signals

Measurement of Short-term Variability of Activation-Recovery Interval on Human Intracardiac Signals - STV-ARI clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48872
Enrollment
20
Registered
2017-12-12
Start date
2018-02-13
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sudden cardiac arrest ventricular arrhythmias

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age 120 ms - Contra-indications for ICD-implantation - Permanent atrial fibrillation - Atrioventricular block, 2nd and 3rd degree

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
-- 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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)