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

NCT01254474 | Completed

• 1 other identifier: CHUBX 2010/42
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Ventricular Fibrillation; Junctional Tachycardia

Keywords

Depolarization, tissue; Repolarization, tissue; Cardiac Arrhythmias; Action potentials, monophasic; Mapping, Catheter; Cardiac activation

Outcome Measures

Primary Outcomes (1)

• 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.

  End of mapping procedure (up to 5 days after inclusion)

Secondary Outcomes (4)

• Presence of zone of low voltage (<0.5 mV)

  End of mapping procedure (up to 5 days after inclusion)

• Presence of post depolarization on MAP4 catheter

  End of mapping procedure (up to 5 days after inclusion)

• Adverse events during procedure and/or during 6 months

  6 months

• Skin to skin procedural time

  End of mapping procedure (up to 5 days after inclusion)

Study Arms (1)

MAP 4 procedure

EXPERIMENTAL

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

Device: Cardiac chambers mapping with MAP 4

Interventions

Cardiac chambers mapping with MAP 4 DEVICE

MAP 4 procedure

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department

Pessac, 33604, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Ventricular Fibrillation; Tachycardia, Ectopic Junctional; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Supraventricular; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Mélèze HOCINI, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 6, 2010
• Study Start: January 17, 2011
• Primary Completion: October 1, 2015
• Study Completion: April 12, 2016
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

FR (1)