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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01254474
First received: December 1, 2010
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Ventricular Fibrillation
Junctional Tachycardia
Device: Cardiac chambers mapping with MAP 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Cardiac activation identified during the intervention by depolarization and repolarization times [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ] [ Designated as safety issue: No ]

    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) [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ] [ Designated as safety issue: No ]
  • Presence of post depolarization on MAP4 catheter [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ] [ Designated as safety issue: No ]
  • Adverse events during procedure and/or during 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Skin to skin procedural time [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ] [ Designated as safety issue: No ]
    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))


Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAP 4 procedure
Assess MAP 4 mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's
Device: Cardiac chambers mapping with MAP 4

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01254474

Locations
France
Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Mélèze HOCINI, MD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01254474     History of Changes
Other Study ID Numbers: CHUBX 2010/42
Study First Received: December 1, 2010
Last Updated: April 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Depolarization, tissue
Repolarization, tissue
Cardiac Arrhythmias
Action potentials, monophasic
Mapping, Catheter
Cardiac activation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Tachycardia
Tachycardia, Ectopic Junctional
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Supraventricular

ClinicalTrials.gov processed this record on August 20, 2014