Utility of ICD Electrograms During Ventricular Tachycardia Ablation

Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures

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 Overview

• Status: Completed
• Conditions: Sustained Monomorphic Ventricular Tachycardia
• Intervention / Treatment: Procedure: Conventional RF catheter ablation; Procedure: Investigational RF Catheter Ablation using ICD-EG information

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Hospital General Universitario
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Bilbao, Spain
    • Hospital Universitario de Basurto
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Granada, Spain
    • Hospital Universitario Virgen de las Nieves
  • Las Palmas, Spain
    • Hospital Universitario Insular de Gran Canaria
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain
    • HM hospitales
  • Murcia, Spain
    • Hospital Universitario Virgen de la Arrixaca
  • Sevilla, Spain
    • Hospital Universitario Nuestra Señora de Valme
  • Toledo, Spain
    • Hospital Virgen De La Salud
  • Valencia, Spain
    • Hospital Clinico Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional RF catheter ablation; Conventional RF ablation will be performed without using ICD-EG information	Procedure: Conventional RF catheter ablation; 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).
Other: Investigational RF Catheter Ablation using ICD-EG information; RF Catheter Ablation will be performed using ICD-EG information	Procedure: Investigational RF Catheter Ablation using ICD-EG information; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients free of VT recurrence	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in number of VT recurrence		6 months
Reduction in the proportion of patients free of VT recurrence		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		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.	6 months

Collaborators and Investigators

• Sponsor: Fundación Hospital de Madrid
• Investigators: Study Director: Jesus Almendral, MD, HM hospitales

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: September 14, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: AIDEG-VTA