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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 Bi-zone 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. | 30 min |
| LV pacing success rate | Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms. | 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Device or Implant testing procedure-related Adverse Events | 1 month post intervention | |
| Electrical performance (1) | LV pacing threshold (Volt) | 30 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 | ||||
| Clermont-Ferrand University Hospital |
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| Electrical performance (2) | LV pacing impedance (Ohm) | 30 min |
| AXONE Implant Efficiency (1) | procedure time for successful placement | 30 min |
| AXONE Implant Efficiency (2) | fluoroscopic time | 30 min |
| AXONE Implant Efficiency (3) | radiation dose | 30 min |
| AXONE Implant Efficiency (4) | handling assessment. | 30 min |
| LV multipoint pacing success | the placement of the AXONE provides two pacing vectors matching | 30 min |
| Clermont-Ferrand |
| France |
| Lille University Hospital | Lille | France |
| Rennes University Hospital | Rennes | France |
| Rouen University Hospital | Rouen | France |
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | Spain |