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OpenTrials
Completed

NCT Number: NCT02274168

Utility of ICD Electrograms During Ventricular Tachycardia Ablation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario, Alicante, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional RF catheter ablation

Procedure

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).

Investigational RF Catheter Ablation using ICD-EG information

Procedure

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.

Primary outcomes

  1. Percentage of patients free of VT recurrence

    Time frame: 6 months

Secondary outcomes

  1. Reduction in number of VT recurrence

    Time frame: 6 months

  2. Reduction in the proportion of patients free of VT recurrence

    Time frame: 6 months

  3. 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

  4. Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación Hospital de Madrid

Other

Registry information

Official study title

Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2014
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.