Utility of ICD Electrograms During Ventricular Tachycardia Ablation

Not Applicable

Completed

• Conditions: Sustained Monomorphic Ventricular Tachycardia
• Interventions: Procedure: Conventional RF catheter ablation; Procedure: Investigational RF Catheter Ablation using ICD-EG information

• Registration Number: NCT02274168
• Lead Sponsor: Fundación Hospital de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-09-14
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional RF catheter ablation	Conventional RF catheter ablation	Conventional RF ablation will be performed without using ICD-EG information
Investigational RF Catheter Ablation using ICD-EG information	Investigational RF Catheter Ablation using ICD-EG information	RF Catheter Ablation will be performed using ICD-EG information

Primary Outcome Measures

Name	Time	Method
Percentage of patients free of VT recurrence	6 months

Secondary Outcome Measures

Name	Time	Method
Reduction in number 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
Reduction in the proportion of patients free of VT recurrence	6 months
Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added	6 months	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.

Trial Locations

Locations (14)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Spain

HM Hospitales; 🇪🇸 Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital General Universitario; 🇪🇸 Alicante, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario Insular de Gran Canaria; 🇪🇸 Las Palmas, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain