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This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm- Foresight ICE System | Experimental | This open label feasibility study will evaluate the Foresight ICE system for imaging chambers of the heart and guiding transseptal puncture during an atrial fibrillation (AF) ablation procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foresight ICE System | Device | The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device | During ablation procedure (2-4 h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Verma, MD | Southlake Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y2P6 | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |