Ventricular TachycardiaEPICONTAC-VTNCT01847378
Feasibility of Contact Force Catheter Mapping and Ablation in Epicardial and Endocardial Ventricular Tachycardias
An observational study of Ventricular Tachycardia and Sudden Death, run by Federal University of São Paulo at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia, Sudden Death, Syncope
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 3 sitesBrazil
- Study dates
- Jun 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chagasic patients with symptomatic documented ventricular tachycardia
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- patients with implantable devices (pacemakers, implantable defibrillators and similar)
- coagulopathy (INR > 1,5 or aPTT 2x normal values)
- platelet count inferior to 100.000
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Federal University of São Paulo, São Paulo Hospital
São Paulo, São Paulo, 04024-002
Enia L Coutinho, coordinator, +55(11)992914070, coutinho.enia@gmail.com
Lucas H Oliveira, MD
- Recruiting
Federal University of São Paulo
São Paulo, São Paulo, 04024-002
Lucas H Oliveira, MD, Msc, +55(11)99975-0937, lucas.hollanda@unifesp.br
Angelo AV de Paola, MD, pHD
- Not yet recruiting
Federal University of São Paulo
São Paulo, São Paulo, SP
Enia L Coutinho, Coordinator, +55(11)992914070, coutinho.enia@gmail.com
Lucas H Oliveira, MD
About this study
Official title: 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.
- Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on 3T MRI
- Correlate areas of late activation within scar during activating mapping in sinus rhythm with different signal intensity in 3T MRI
- Evaluate the influence of contact pressure during application of radiofrequency in making fibrosis analyzed 30 days after the procedure using a 3T MRI.
- 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
- Being tested
- Catheter ablation
- Keywords
- ventricular tachycardia, catheter ablation, chagas disease, epicardial mapping, magnetic resonance imaging
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Syncope, Chest Pain, Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Patients with chronic chagasic disease and documented monomorphic ventricular tachycardia Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediatly after the procedure
Secondary outcomes (1)
Evaluate the impedance and voltage threshold for scar in chronic chagasic cardiomyopathy
Measured: After the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Hollanda, Federal University of São Paulo
- Investigators
- Claudio Cirenza, MD, PhD, Study director, Federal University of São PauloAngelo AV de Paola, MD, PhD, Study chair, Federal University of São PauloLucas H Oliveira, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847378
- Sponsor's protocol ID
- ISII
- Acronym
- EPICONTAC-VT
- Status last verified
- Oct 2014
- First submitted
- 2 May 2013
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIcardial and Endocardial Mapping and Ablation Using Contact Force Catheter in Chagasic Patients With Sustained Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT01847378
- Acronym / sponsor ID
- EPICONTAC-VT / ISII
- Conditions
- Ventricular Tachycardia, Sudden Death, Syncope, Chest Pain
- Keywords
- ventricular tachycardia, catheter ablation, chagas disease, epicardial mapping, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 6 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on 3T MRI
- Correlate areas of late activation within scar during activating mapping in sinus rhythm with different signal intensity in 3T MRI
- Evaluate the influence of contact pressure during application of radiofrequency in making fibrosis analyzed 30 days after the procedure using a 3T MRI.
- Assess the site of latest left ventricular activation in sinus rhythm and correlate with the coronary veins location
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | – | Procedure: Catheter ablationPatients with chronic chagasic disease and documented monomorphic ventricular tachycardia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chagasic patients with symptomatic documented ventricular tachycardia
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationDuring mapping and ablation tissue voltage and impedance will be stored and analyzed thereafter. The same procedure will be done in regard to activating maps. | Procedure or surgery | Catheter ablation |
Primary outcome
Evaluate the feasibility of mapping and ablating ventricular tachycardias in endocardial and epicardial using a contact force catheter
Time frame: Immediatly after the procedure
The feasibility will be evaluated immediatly after the procedure
1 secondary outcome
Evaluate the impedance and voltage threshold for scar in chronic chagasic cardiomyopathy
Time frame: After the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Cirenza, MD, PhD study director
Federal University of São Paulo
Angelo AV de Paola, MD, PhD study chair
Federal University of São Paulo
Lucas H Oliveira, MD principal investigator
Federal University of São Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Sudden Death, run by Federal University of São Paulo at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas H Oliveira, MD (+55(11)99750937 ext. 55, lucas.hollanda@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of mapping and ablating ventricular tachycardias in endocardial and epicardial using a contact force catheter (time frame: Immediatly after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.