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This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. All electrophysiology studies and/or ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Torque Device | Experimental | After the completion of the electrophysiology study and/or ablation procedure, the catheters remain in the intra-cardiac locations. While in place, measurements will be obtained from each catheter. Once the baseline measurements have been obtained, the Peritorq device will be placed onto each relevant catheter. Once secured, all measurements will be repeated with each catheter at the identical location. After measurements have been obtained, the operator will perform minor catheter movements to note subjective maneuverability and stability of the catheter with the torque device in place |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritorq | Device | Novel torque device specifically designed for electrophysiology and ablation catheters |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Impedance | Obtained from catheter at baseline and after Peritorq device placed | 15 minutes |
| Difference in Sensing of Chamber Amplitude (mV) | Obtained from catheter at baseline and after Peritorq device placed | 15 minutes |
| Difference in Capture Threshold of Atrium and Ventricle (mA) | Obtained from catheter at baseline and after Peritorq device placed | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bradley Clark | Contact | (612) 626-2755 | clarkb@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bradley Clark | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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