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Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter (EvaMAP)

Primary Purpose

Atrial Fibrillation, Ventricular Fibrillation, Junctional Tachycardia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac chambers mapping with MAP 4
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Depolarization, tissue, Repolarization, tissue, Cardiac Arrhythmias, Action potentials, monophasic, Mapping, Catheter, Cardiac activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Atrial Fibrillation or Ventricular Fibrillation or junctional tachycardia or reentrant tachycardia
  • Age ≥ 18 years old
  • Signed patient informed consent form
  • Affiliated to social security (European countries)

Exclusion Criteria:

  • Patients under 18 years old
  • Pregnancy
  • Psychiatric disorders
  • Neurological sequelae after a prior cardiac arrest that prevents informed consent
  • Absence of informed consent form

Sites / Locations

  • Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MAP 4 procedure

Arm Description

Assess MAP 4 mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's

Outcomes

Primary Outcome Measures

Cardiac activation identified during the intervention by depolarization and repolarization times
The performance criteria of this MAP4 catheter will be evaluated in providing information on the action potentials to further improve insight into mechanisms. Cardiac activation (depolarization and repolarization) identified during the intervention with established criteria: abnormal depolarization will be defined by a local delay of conduction >25 ms. abnormal repolarization will be defined if a gradient of repolarization > 50 ms.

Secondary Outcome Measures

Presence of zone of low voltage (<0.5 mV)
Presence of post depolarization on MAP4 catheter
Adverse events during procedure and/or during 6 months
Skin to skin procedural time
Skin to skin procedural time (major reduction of time mapping is expected with MAP4. This variable is appreciated by the duration of the procedure and fluoroscopic time (in minutes))

Full Information

First Posted
December 1, 2010
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01254474
Brief Title
Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter
Acronym
EvaMAP
Official Title
Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2011 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Monophasic action potential (MAP) recording plays an important role in a more direct view of human myocardial electrophysiology under both physiological and pathological conditions. The MAP method represents a very useful tool for an electrophysiological research in cardiology. Its crucial importance lies in the fact that it enables the study of the action potential (AP) of myocardial cell in vivo and, therefore, the study of the dynamic relation of this potential with all the organism variables what can be particularly helpful in the case of arrhythmias. Hundred and fifty patients will be included to explore mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's with the following inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular fibrillation or patients at high risk of sudden cardiac death at a total of 50 patients iii) Junctional tachycardia at a total of 50 patients. We will focus on cardiac activation (depolarization and repolarization) in this population.
Detailed Description
This is a prospective descriptive study including 1 French centre The arrhythmogenic substrate that leads to fibrillating heart is poorly understood. This has hindered the development of methods for better understanding mechanisms. The development of better adapted tools to improve understanding and assessment of this substrate is crucial. The current electrophysiological study preceding the ablation is exclusively based on substrate depolarisation potential. It is very powerful when the arrhythmia is organized but limited during fibrillation due to incessant changes in activation. Therefore, potentials of repolarization are better suited for the explorations of fibrillations because they provide basic properties such as refractory period and tissue heterogeneity in arrhythmia, but also in sinus rhythm. Monophasic Action Potential catheters (MAP EFA Boston and MAP Biosense Webster) are available for many years and represent a very useful tool in cardiology in identifying critical areas to arrhythmias (mapping of depolarization and cardiac repolarization). However, their capacity to record action potential is limited because they have one electrode that allows "point-to-point" mapping by moving the catheter sequentially in the cardiac cavities. Moreover, it is difficult to obtain one action potential due to the configuration or the angle of contact of the catheter with the cardiac wall. We want to evaluate a new MAP catheter (MAP4, Medtronic) to assess cardiac depolarization and repolarization. This catheter was developed to allow recording of an action potential whenever the catheter touches the heart wall and whatever the configuration or contact angle. It appears identical to other catheters but is equipped with 4 spherical microelectrodes at its end. Each microelectrode is arranged to one of the 4 'cardinal points' which allows easily simultaneous recording of 4 actions potential. Hundred and fifty patients will be included to explore mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's with the following inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular fibrillation or patients at high risk of sudden cardiac death at a total of 50 patients iii) Junctional tachycardia at a total of 50 patients. We will focus on cardiac activation (depolarization and repolarization) in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Ventricular Fibrillation, Junctional Tachycardia
Keywords
Depolarization, tissue, Repolarization, tissue, Cardiac Arrhythmias, Action potentials, monophasic, Mapping, Catheter, Cardiac activation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAP 4 procedure
Arm Type
Experimental
Arm Description
Assess MAP 4 mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's
Intervention Type
Device
Intervention Name(s)
Cardiac chambers mapping with MAP 4
Primary Outcome Measure Information:
Title
Cardiac activation identified during the intervention by depolarization and repolarization times
Description
The performance criteria of this MAP4 catheter will be evaluated in providing information on the action potentials to further improve insight into mechanisms. Cardiac activation (depolarization and repolarization) identified during the intervention with established criteria: abnormal depolarization will be defined by a local delay of conduction >25 ms. abnormal repolarization will be defined if a gradient of repolarization > 50 ms.
Time Frame
End of mapping procedure (up to 5 days after inclusion)
Secondary Outcome Measure Information:
Title
Presence of zone of low voltage (<0.5 mV)
Time Frame
End of mapping procedure (up to 5 days after inclusion)
Title
Presence of post depolarization on MAP4 catheter
Time Frame
End of mapping procedure (up to 5 days after inclusion)
Title
Adverse events during procedure and/or during 6 months
Time Frame
6 months
Title
Skin to skin procedural time
Description
Skin to skin procedural time (major reduction of time mapping is expected with MAP4. This variable is appreciated by the duration of the procedure and fluoroscopic time (in minutes))
Time Frame
End of mapping procedure (up to 5 days after inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Atrial Fibrillation or Ventricular Fibrillation or junctional tachycardia or reentrant tachycardia Age ≥ 18 years old Signed patient informed consent form Affiliated to social security (European countries) Exclusion Criteria: Patients under 18 years old Pregnancy Psychiatric disorders Neurological sequelae after a prior cardiac arrest that prevents informed consent Absence of informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mélèze HOCINI, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter

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