Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter (EvaMAP)
|ClinicalTrials.gov Identifier: NCT01254474|
Recruitment Status : Suspended
First Posted : December 6, 2010
Last Update Posted : April 25, 2013
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 or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Ventricular Fibrillation Junctional Tachycardia||Device: Cardiac chambers mapping with MAP 4||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||January 2014|
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
- Cardiac activation identified during the intervention by depolarization and repolarization times [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ]
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.
- Presence of zone of low voltage (<0.5 mV) [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ]
- Presence of post depolarization on MAP4 catheter [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ]
- Adverse events during procedure and/or during 6 months [ Time Frame: 6 months ]
- Skin to skin procedural time [ Time Frame: End of mapping procedure (up to 5 days after inclusion) ]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))
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254474
|Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department|
|Pessac, France, 33604|
|Principal Investigator:||Mélèze HOCINI, MD||University Hospital Bordeaux, France|