Atrial Fibrillation
Conditions
Brief summary
This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.
Detailed description
This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.
Interventions
DEVICEForesight ICE System
The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.
Sponsors
Conavi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old. * Patient is undergoing an atrial fibrillation ablation procedure. * Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus. * Patient provides informed, written consent for participation in the study.
Exclusion criteria
* Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure). * Patients in whom transseptal puncture is relatively contraindicated. * Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk. * Women of child bearing potential, in whom pregnancy cannot be excluded. * Patients unable to grant informed, written consent for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device | During ablation procedure (2-4 h) |
Countries
Canada
Outcome results
None listed