Feasibility of Contact Force Catheter Mapping and Ablation in Epicardial and Endocardial Ventricular Tachycardias

NCT01847378 | Unknown

• 1 other identifier: ISII
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on 3T MRI
2. 2.Correlate areas of late activation within scar during activating mapping in sinus rhythm with different signal intensity in 3T MRI
3. 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. 4.Assess the site of latest left ventricular activation in sinus rhythm and correlate with the coronary veins location

Conditions

Ventricular Tachycardia; Sudden Death; Syncope; Chest Pain

Keywords

ventricular tachycardia; catheter ablation; chagas disease; epicardial mapping; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the impedance and voltage threshold for scar in chronic chagasic cardiomyopathy

  After the procedure

Study Arms (1)

Catheter ablation

Patients with chronic chagasic disease and documented monomorphic ventricular tachycardia

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

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.

Catheter ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chagasic patients with symptomatic documented ventricular tachycardia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (3)

Federal University of São Paulo, São Paulo Hospital

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Federal University of São Paulo

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Federal University of São Paulo

São Paulo, São Paulo, SP, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular; Death, Sudden; Syncope; Chest Pain; Chagas Disease

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pain; Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Claudio Cirenza, MD, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

• Angelo AV de Paola, MD, PhD

  Federal University of São Paulo

  STUDY CHAIR

• Lucas H Oliveira, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas H Oliveira, MD

CONTACT

+55(11)99750937; lucas.hollanda@unifesp.br

Enia L Coutinho, Coordinator

CONTACT

+55(11)992914070; coutinho.enia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

BR (3)