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Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.
Success was defined as an absence of phrenic nerve stimulation (threshold > 7V) or in case of phrenic nerve stimulation occurrence (threshold < 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.
Any occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Resynchronization Therapy-Defibrillator | Experimental | Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France) | Device | Patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator (model PARADYM RF SONR CRT-D 9770 or PARADYM RF CRT-D 9750, Sorin) having 3 left ventricular polarities. The choice of the right atrial, right ventricular and bipolar left ventricular leads was left to investigators' discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Phrenic nerve stimulation measurement | The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer | The presence of phrenic nerve stimulation will be assessed at implant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri BENKEMOUN | Clinique Saint Pierre - Perpignan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy | Annecy | France | ||||
| Hopital Henri Mondor |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Créteil |
| France |
| CH LENS | Lens | 62307 | France |
| CH de Bretagne Sud | Lorient | 56322 | France |
| Clinique Clairval | Marseille | 13000 | France |
| CHP Beauregard | Marseille | 13012 | France |
| Clinique Montpellier | Montpellier | France |
| Polyclinique de Gentilly | Nancy | 54100 | France |
| CHU Groupe Hospitalo-universitaire Caremeau | Nîmes | 30029 | France |
| Hopital de La Source | Orléans | 45067 | France |
| CH St Joseph | Paris | France |
| Clinique St Pierre | Perpignan | France |