Clinical Utility and Validation of the Rhythmia Mapping System for the Treatment of Cardiac Arrhythmias

CompletedOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

January 13, 2015

Primary Completion Date

December 1, 2015

Study Completion Date

December 1, 2015

Conditions
Cardiac ArrhythmiasElectroanatomic MappingCardiac Ablation
Interventions
DEVICE

Rhythmia Mapping System

Arrhythmia mapping will be performed using the Rhythmia mapping system, including its mapping catheter, either in the atria or ventricles depending on the clinical arrhythmia being treated. Detailed mapping will be performed to determine tissue voltage and arrhythmia mechanism/location according to standard clinical practice. This part of the study will take approximately 90-120 minutes. The catheter position and contact will be visualized with intra-cardiac echocardiography, which is also routinely used during these procedures, and to monitor for potential clinically related complications. Images will be recorded to establish criteria for mapping.

Trial Locations (1)

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Beth Israel Deaconess Medical Center

OTHER