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Therapy Cool Path Duo · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Therapy Cool Path Duo | DEVICE | All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter. |
Inclusion Criteria: * A signed written Informed Consent * Presence of typical atrial flutter (cavotricuspid isthmus dependent) * If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an arrhythmia other than typical atrial flutter, then the subject needs to be controll...
Therapy Cool Path Duo is a cardiac ablation system used for the treatment of typical atrial flutter, a type of abnormal heart rhythm. It is an investigational device that was evaluated in a clinical study for this condition.
Therapy Cool Path Duo is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The device is part of Abbott's cardiovascular product portfolio.
Therapy Cool Path Duo is in Phase 3 clinical development. It has completed one Phase 3 trial, but it remains an investigational device and is not yet approved for commercial use.
Therapy Cool Path Duo has one completed clinical trial, identified as NCT00984204. This Phase 3 study evaluated the device for the treatment of typical atrial flutter and enrolled 188 participants in the United States and Canada.
Therapy Cool Path Duo is not FDA approved. It is an investigational device that has completed a Phase 3 clinical trial, but approval status has not been established based on available information.