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

EPIcardial and Endocardial Mapping and Ablation Using Contact Force Catheter in Chagasic Patients With Sustained Ventricular Tachycardia

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

Study Overview

• Status: Unknown
• Conditions: Chest Pain; Syncope; Ventricular Tachycardia; Sudden Death
• Intervention / Treatment: Procedure: Catheter ablation

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Lucas H Oliveira, MD; Phone Number: 55 +55(11)99750937; Email: lucas.hollanda@unifesp.br
• Study Contact Backup: Name: Enia L Coutinho, Coordinator; Phone Number: +55(11)992914070; Email: coutinho.enia@gmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Recruiting
    • Federal University of São Paulo, São Paulo Hospital
    • Contact: Enia L Coutinho, Coordinator; Phone Number: +55(11)992914070; Email: coutinho.enia@gmail.com
    • Principal Investigator: Lucas H Oliveira, MD
  • São Paulo, Brazil, 04024-002
    • Recruiting
    • Federal University of São Paulo
    • Contact: Lucas H Oliveira, MD, Msc; Phone Number: +55(11)99975-0937; Email: lucas.hollanda@unifesp.br
    • Sub-Investigator: Angelo AV de Paola, MD, pHD
    • Sub-Investigator: Claudio Cirenza, MD, pHD
  • São Paulo, Brazil, SP
    • Not yet recruiting
    • Federal University of São Paulo
    • Contact: Enia L Coutinho, Coordinator; Phone Number: +55(11)992914070; Email: coutinho.enia@gmail.com
    • Principal Investigator: Lucas H Oliveira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chagasic patients with symptomatic documented ventricular tachycardia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the feasibility of mapping and ablating ventricular tachycardias in endocardial and epicardial using a contact force catheter	The feasibility will be evaluated immediatly after the procedure	Immediatly after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the impedance and voltage threshold for scar in chronic chagasic cardiomyopathy	After the procedure

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; catheter ablation; ventricular tachycardia; chagas disease; epicardial mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Death; Unconsciousness; Consciousness Disorders; Chest Pain; Tachycardia; Tachycardia, Ventricular; Syncope; Death, Sudden
• Other Study ID Numbers: ISII