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| Name | Class |
|---|---|
| MicroPort CRM | INDUSTRY |
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Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant test procedure | Experimental | Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant test procedure | Device | Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| LV Multizone pacing success rate | Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms | 20 min |
| LV pacing success rate | Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms | 20 min |
| Measure | Description | Time Frame |
|---|---|---|
| Implant testing Procedure-related Adverse Events procedure. | 1 month post testing | |
| Electrical performance of device (1) | Electrical performance focusing on LV pacing threshold (Volts) | 20 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric ANSELME, Pr | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | France | ||||
| Lille University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33504741 | Result | Anselme F, Albatat M, Marquie C, Leclercq C, Ritter P, Ollivier JF, Shan N, Ziglio F, Feuerstein D. Exploring a New Systematic Route for Left Ventricular Pacing in Cardiac Resynchronization Therapy. Circ J. 2021 Feb 25;85(3):283-290. doi: 10.1253/circj.CJ-20-0266. Epub 2021 Jan 27. |
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| Electrical performance of device (2) | Electrical performance focusing on LV pacing impedance (Ohm) | 20 min |
| Lead Implant Efficiency | procedure time for successful placement | 20 min |
| Lead Implant Efficiency | Radiation dose during implant | 20 min |
| Satisfaction of implanter | handling assessment of implanter using satisfaction scale | 20 min |
| Lille |
| France |
| Rennes University Hospital | Rennes | France |
| Rouen University Hospital | Rouen | France |