Clinical trial NCT02274168: Utility of ICD Electrograms During Ventricular Tachycardia Ablation
Official title: Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sustained Monomorphic Ventricular Tachycardia
Lead sponsor: Fundación Hospital de Madrid
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Clinical indication for RF catheter ablation
* Presence of an implanted ICD
* At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
* Presence of structural heart disease
* Able to obtain signed informed consent and willing to comply with study activity requirements

Exclusion Criteria:

* It is anticipated that data can not be obtained during follow-up
* Unwilling or unable to provide informed consent
* Women who are or may potentially be pregnant
* Patients who are participating in another clinical trial

Primary outcomes:
measure: Percentage of patients free of VT recurrence
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in number of VT recurrence
timeFrame: 6 months
measure: Reduction in the proportion of patients free of VT recurrence
timeFrame: 6 months
measure: 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
timeFrame: 6 months and total follow-up
measure: Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added
timeFrame: 6 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Las Palmas
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Madrid
country: Spain
facility: HM Hospitales
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: HM hospitales
name: Jesus Almendral, MD
role: STUDY_DIRECTOR
References:
citation: Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043.
citation: Almendral J, Marchlinski F. Is it the same or a different ventricular tachycardia?: an additional use for defibrillator electrograms. J Am Coll Cardiol. 2010 Sep 14;56(12):980-2. doi: 10.1016/j.jacc.2010.03.081. No abstract available.
citation: Almendral J, Atienza F, Everss E, Castilla L, Gonzalez-Torrecilla E, Ormaetxe J, Arenal A, Ortiz M, Sanroman-Junquera M, Mora-Jimenez I, Bellon JM, Rojo JL. Implantable defibrillator electrograms and origin of left ventricular impulses: an analysis of regionalization ability and visual spatial resolution. J Cardiovasc Electrophysiol. 2012 May;23(5):506-14. doi: 10.1111/j.1540-8167.2011.02233.x. Epub 2011 Dec 8.