With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
RF catheter ablation will be performed as usually done by each center. No ICD EGMs will be obtained and used during the ablation procedure (do not place the programming head over the ICD generator).
RF ablation procedure will be performed with the programming head over the ICD generator. ICD EGMs will be registered every time VT is induced and during ventricular pacing. ICD EGMs obtained during ablation procedure will be compared with the EGMs of the registered spontaneus VT and used to locate appropriate ablation sites.
Hospital General Universitario
Alicante, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas, Spain
HM Hospitales
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
...and 4 more locations
Percentage of patients free of VT recurrence
Time frame: 6 months
Reduction in number of VT recurrence
Time frame: 6 months
Reduction in the proportion of patients free of VT recurrence
Time frame: 6 months
Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced
Time frame: 6 months and total follow-up
Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added
This outcome will be studied from the stored signal together with the ICD-EG on the device in the subgroup of patients with a device that allows to obtain this parameter. In the remaining patients, signals will be obtained noninvasively with a seismocardiogram using a highly sensitive accelerometer located in the sternal midline of the xiphoid process and simultaneously synchronized with the ECG.
Time frame: 6 months
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