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The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:
The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture.
Then, the ICD devices have 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 the PARADYM RF clinical study, the sponsor aims at:
Thus, this study intends to show that PARADYM RF ICDs operate safely and appropriately in intended-use as part of an ICD system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paradym RF ICD | Experimental | Active implantable defibrillators range |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR 9250 / DR 9550 / CRT 9750 | Device | Active implantable defibrillators range |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of the Right ventricular (RV) autothreshold algorithm performances | Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Any adverse event will be documented throughout 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 |
|---|---|---|
| Sack SS Stefan, Pr | Klinikum Schwabing München Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sack | München | 80804 | Germany |
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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 left ventricular lead performances | Report the electrical performances and lead mechanical handling at implant. | 12 months |
| Evlauation of the Remote Monitoring Solution | Ensure the Home Monitoring setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician. | 12 months |