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Clinical Trials/NCT02274168
NCT02274168
Completed
N/A

Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures

Fundación Hospital de Madrid14 sites in 1 country260 target enrollmentApril 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sustained Monomorphic Ventricular Tachycardia
Sponsor
Fundación Hospital de Madrid
Enrollment
260
Locations
14
Primary Endpoint
Percentage of patients free of VT recurrence
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
March 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundación Hospital de Madrid
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Percentage of patients free of VT recurrence

Time Frame: 6 months

Secondary Outcomes

  • 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)

Study Sites (14)

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