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SmartTouch Catheter in Ablation of Ventricular Tachycardia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Arcadio Garcia Alberola, Hospital Universitario Virgen de la Arrixaca.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639365
First Posted: July 12, 2012
Last Update Posted: September 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Arcadio Garcia Alberola, Hospital Universitario Virgen de la Arrixaca
  Purpose
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.

Condition
Arrhythmias, Cardiac Tachycardia, Ventricular Myocardial Infarction Cardiomyopathies

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 Arcadio Garcia Alberola, 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 ]
    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)
  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639365


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

Additional Information:
Publications:
Responsible Party: Arcadio Garcia Alberola, Professor of Cardiology, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT01639365     History of Changes
Other Study ID Numbers: IIS-176
First Submitted: July 10, 2012
First Posted: July 12, 2012
Last Update Posted: September 7, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Tachycardia, Ventricular
Infarction
Myocardial Infarction
Cardiomyopathies
Tachycardia
Arrhythmias, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases