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Utility of ICD Electrograms During Ventricular Tachycardia Ablation

NCT02274168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2022-12-13

No results posted yet for this study

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.

Conditions

  • Sustained Monomorphic Ventricular Tachycardia

Interventions

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).

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.

Sponsors & Collaborators

  • Fundación Hospital de Madrid

    lead OTHER

Principal Investigators

  • Jesus Almendral, MD · HM hospitales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02274168 on ClinicalTrials.gov