SmartTouch Catheter in Ablation of Ventricular Tachycardia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hospital Universitario Virgen de la Arrixaca.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Arcadio Garcia Alberola, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT01639365
First received: July 10, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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 Hospital Universitario Virgen de la Arrixaca:

Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639365

Contacts
Contact: Arcadi Garcia-Alberola, MD +34968369211 arcadi@secardiologia.es

Locations
Spain
University Hospital Virgen de la Arrixaca Recruiting
Murcia, Spain, 30120
Contact: Pablo Peñafiel, MD    +34968369211      
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
Biosense Webster, Inc.
Investigators
Principal Investigator: Arcadi Garcia-Alberola, MD University Hospital Virgen de la Arrixaca.
  More Information

No publications provided

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
Study First Received: July 10, 2012
Last Updated: July 10, 2012
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:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Infarction
Myocardial Infarction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on September 11, 2014