SmartTouch Catheter in Ablation of Ventricular Tachycardia

This study is ongoing, but not recruiting participants.
Biosense Webster, Inc.
Information provided by (Responsible Party):
Arcadio Garcia Alberola, Hospital Universitario Virgen de la Arrixaca Identifier:
First received: July 10, 2012
Last updated: September 4, 2015
Last verified: September 2015
The pressure exerted by the ablation catheter on the tissue has been shown to play an important role on determining the size and the potential efficacy of the ablation lesions. A direct information on the force exerted by the catheter tip obtained from the SmartTouch technology might improve the assessment of the scar areas during electroanatomical mapping in patients with ventricular tachycardia (VT) due to ischemic disease or cardiomyopathy. The objectives of the study are to compare the areas of scar (defined as a low-voltage threshold) obtained from the conventional voltage map with those obtained after the contact map information is available to the operator and to determine if the availability of the contact information allows an improvement of the electroanatomic map by correcting the points taken in no-contact areas. Twenty to 30 consecutive patients with ventricular arrhythmias due to ischemic heart disease or dilated cardiomyopathy undergoing VT ablation will be included in a prospective, one-center, non-randomized study. A voltage map of the left ventricle will be obtained using the CARTO-3 navigation system and the scar areas as well as the areas of potential interest for ablation will be delineated in the standard way and saved as the control map. The force information will be recorded by the system but will not be available to the operator until the control map is saved. Following this step the contact map will be available to the operator to be compared with the control map and further mapping and point acquisition will be allowed to correct the areas previously acquired with poor or no contact. The final map after corrections have been made will be saved as the corrected map. The ablation procedure will then be performed as usual. Both maps will be compared in a deferred way to know how are classified the areas without contact when no pressure information is available, and how many non-contact points are falsely assumed to be low-voltage or dense scar points. These comparisons will give information on how much the standard electroanatomic map can be improved when the force information is added.

Arrhythmias, Cardiac
Tachycardia, Ventricular
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usefulness of the SmartTouch Catheter to Assess the Areas of Myocardial Scar in Patients With Ventricular Tachycardia

Resource links provided by NLM:

Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Primary Outcome Measures:
  • Comparison of the scarred areas obtained by traditional voltage mapping with those obtained using a map that includes the contact force information in patients with VT [ Time Frame: During ablation procedure ] [ Designated as safety issue: No ]
    The size of the scars, the abnormal potentials, and the channels detected in the control map were compared with those of the final map

Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with ventricular arrhythmias due to ischemic heart disease or dilated cardiomyopathy undergoing VT ablation

Inclusion Criteria:

  • Consecutive patients with ventricular arrhythmias due to ischemic heart disease or dilated cardiomyopathy undergoing VT ablation

Exclusion Criteria:

  • Age <18 years, absence of signed informed consent or critical clinical status that precludes a detailed mapping procedure
  Contacts and Locations
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Please refer to this study by its identifier: NCT01639365

University Hospital Virgen de la Arrixaca
Murcia, Spain, 30120
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
Biosense Webster, Inc.
Principal Investigator: Arcadi Garcia-Alberola, MD Hospital Universitario Virgen de la Arrixaca
  More Information

Additional Information:
Responsible Party: Arcadio Garcia Alberola, Professor of Cardiology, Hospital Universitario Virgen de la Arrixaca Identifier: NCT01639365     History of Changes
Other Study ID Numbers: IIS-176
Study First Received: July 10, 2012
Last Updated: September 4, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario Virgen de la Arrixaca:
Ventricular tachycardia
Catheter ablation
Tissue contact

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Myocardial Infarction
Tachycardia, Ventricular
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on November 25, 2015