Feasibility of Contact Force Catheter Mapping and Ablation in Epicardial and Endocardial Ventricular Tachycardias (EPICONTAC-VT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Lucas Hollanda, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01847378
First received: May 2, 2013
Last updated: August 3, 2013
Last verified: August 2013
  Purpose

Ventricular tachycardia is one of the commonest cause of sudden death in chronic chagas disease. As most ventricular tachycardias originate from scar in patients with heart disease, catheter ablation is an important step in patient treatment. Identification of fibrosis prior to ablation of sustained ventricular tachycardia (SVT) might reduce the time of anesthesia, procedure time, radiation exposure and possibly the risk of complications. Knowledge of arrhythmia circuit within scar allows planning strategies for each procedure. Condreanu et al. stablished that voltages inferior to 6.52 mV (unipolar) and 1.54mV (bipolar) are useful tools in detecting scar during electroanatomic mapping. Accuracy, however when compared to magnetic resonance imaging is limited due to difficulties in maintaining good contact between ablation catheter and ventricular wall. Contact force catheters might help increase accuracy of voltage mapping because they allow detection of poor contact areas. Although the threshold for identification of scar in ischemic and non ischemic patients during electroanatomical mapping is already known, this parameters still lacking for chronic chagasic individuals. A marked qualitative histological difference between these fibrous scars supports the hypothesis that voltage scar in chagasics might be different. Catheter ablation contact with endo and epicardial surface is an important issue when ablating arrhythmias. Conventional catheter ablation is not equipped with sensors capable of detecting degree of contact with the target. To our knowledge, the literature lacks information in regard to late lesions produced by a known contact force pressure "in vivo". The pattern of electrical activation in these patients and their relationship with local coronary veins for resynchronization likely to approach through the coronary sinus can be useful in defining chagasic that can benefit from resynchronization.

  1. Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on 3T MRI
  2. Correlate areas of late activation within scar during activating mapping in sinus rhythm with different signal intensity in 3T MRI
  3. Evaluate the influence of contact pressure during application of radiofrequency in making fibrosis analyzed 30 days after the procedure using a 3T MRI.
  4. Assess the site of latest left ventricular activation in sinus rhythm and correlate with the coronary veins location

Condition Intervention
Ventricular Tachycardia
Sudden Death
Syncope
Chest Pain
Procedure: Catheter ablation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EPIcardial and Endocardial Mapping and Ablation Using Contact Force Catheter in Chagasic Patients With Sustained Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Evaluate the feasibility of mapping and ablating ventricular tachycardias in endocardial and epicardial using a contact force catheter [ Time Frame: Immediatly after the procedure ] [ Designated as safety issue: Yes ]
    The feasibility will be evaluated immediatly after the procedure


Secondary Outcome Measures:
  • Evaluate the impedance and voltage threshold for scar in chronic chagasic cardiomyopathy [ Time Frame: After the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Catheter ablation
Patients with chronic chagasic disease and documented monomorphic ventricular tachycardia
Procedure: Catheter ablation
During mapping and ablation tissue voltage and impedance will be stored and analyzed thereafter. The same procedure will be done in regard to activating maps.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chagasic patients with symptomatic documented ventricular tachycardia

Criteria

Inclusion Criteria:

  • individuals aged between 18 and 80 years old
  • life expectancy greater than 1 year
  • positive reaction in at least two different serologic techniques for Chagas disease (ELISA, indirect hemagglutination or indirect immunofluorescence)
  • symptomatic recurrent monomorphic ventricular tachycardia (recorded by holter, electrocardiogram or looper)
  • prior to implantable cardioverter defibrillator implantation in patients with ventricular tachycardia as an attempt to prevent shoks
  • patients in "electrical storm", defined as three or more episodes of ventricular tachycardia in 24h. Each episode must demand a medical intervention.
  • monomorphic ventricular tachycardia induced during electrical physiological study in patients with syncope of unexplained cause

Exclusion Criteria:

  • claustrophobia
  • creatinine clearance inferior to 30ml/min/m2 (clearance between 30ml/min/m2 and 60ml/min/m2 will be analyzed individually)
  • thrombus in the left ventricle
  • pregnancy
  • heart failure NYHA IV
  • allergy to iodinated contrast or gadolinium
  • patients with implantable devices (pacemakers, implantable defibrillators and similar)
  • coagulopathy (INR > 1,5 or aPTT 2x normal values)
  • platelet count inferior to 100.000
  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: NCT01847378

Contacts
Contact: Lucas H Oliveira, MD +55(11)99750937 ext 55 lucas.hollanda@unifesp.br
Contact: Enia L Coutinho, Coordinator +55(11)992914070 coutinho.enia@gmail.com

Locations
Brazil
Federal University of São Paulo Not yet recruiting
São Paulo, Brazil, SP
Contact: Enia L Coutinho, Coordinator    +55(11)992914070    coutinho.enia@gmail.com   
Principal Investigator: Lucas H Oliveira, MD         
Federal University of São Paulo, São Paulo Hospital Recruiting
São Paulo, Brazil, 04024-002
Contact: Enia L Coutinho, coordinator    +55(11)992914070    coutinho.enia@gmail.com   
Principal Investigator: Lucas H Oliveira, MD         
Federal University of São Paulo Recruiting
São Paulo, Brazil, 04024-002
Contact: Lucas H Oliveira, MD, Msc    +55(11)99975-0937    lucas.hollanda@unifesp.br   
Sub-Investigator: Angelo AV de Paola, MD, pHD         
Sub-Investigator: Claudio Cirenza, MD, pHD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Claudio Cirenza, MD, PhD Federal University of São Paulo
Study Chair: Angelo AV de Paola, MD, PhD Federal University of São Paulo
Principal Investigator: Lucas H Oliveira, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Lucas Hollanda, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01847378     History of Changes
Other Study ID Numbers: ISII
Study First Received: May 2, 2013
Last Updated: August 3, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
ventricular tachycardia
catheter ablation
chagas disease
epicardial mapping
magnetic resonance imaging

Additional relevant MeSH terms:
Chest Pain
Death, Sudden
Syncope
Tachycardia
Tachycardia, Ventricular
Pain
Signs and Symptoms
Death
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014