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Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.
The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the physician in his diagnosis avoiding potential lost of capture.
The ICD device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.
Finally, the study will report the electrical and handling performances of the new left ventricular lead.
In this study, the sponsor aims at:
Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT-SonR 9770 | Experimental | Active implantable defibrillator with ability to cardiac resynchronization therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-SonR 9770 | Device | Active implantable defibrillator with capacity of cardiac resynchronization therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the SonR lead safety | Complication free rate of the SonR lead superior to 90 % | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Any adverse will be documented thoughout the study and will be reported. | 12 months |
| ICD electrical performances | Report all ICD electrical performances of the Paradym RF ICD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe CL Leclercq, Ryhtmologist | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leclercq | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 months |
| Evaluation of the SonR atrial lead performance | Report electrical performances and lead handling at implant | 3 months |
| Evaluation of the AV/VV delays optimization | Describe the performances of the manual and automatic AV/VV optimization algorithms. An optional daily life test could be performed to evaluate the automatic optimization at exercise. | 3 months |
| Evaluation of the left ventricular lead performances | Report the electrical performances and lead mechanical handling at implant. | 12 months |
| Evaluation of the Remote Monitoring Solution | Ensure the Home Monitor setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician. | 12 months |
| Evaluation of the right ventricular autothreshold performances | Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V. | 1 month |