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Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 26, 2010
Last Update Posted: June 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
July 20, 2010
July 26, 2010
June 18, 2014
October 2010
June 2011   (Final data collection date for primary outcome measure)
Evaluation of the SonR lead safety [ Time Frame: 3 months ]
Complication free rate of the SonR lead superior to 90 %
Same as current
Complete list of historical versions of study NCT01169272 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events [ Time Frame: 12 months ]
    Any adverse will be documented thoughout the study and will be reported.
  • ICD electrical performances [ Time Frame: 12 months ]
    Report all ICD electrical performances of the Paradym RF ICD
  • Evaluation of the SonR atrial lead performance [ Time Frame: 3 months ]
    Report electrical performances and lead handling at implant
  • Evaluation of the AV/VV delays optimization [ Time Frame: 3 months ]
    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.
  • Evaluation of the left ventricular lead performances [ Time Frame: 12 months ]
    Report the electrical performances and lead mechanical handling at implant.
  • Evaluation of the Remote Monitoring Solution [ Time Frame: 12 months ]
    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.
  • Evaluation of the right ventricular autothreshold performances [ Time Frame: 1 month ]
    Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V.
Same as current
Not Provided
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Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform

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:

  • Demonstrating the safety of the atrial SonR lead;
  • Demonstrating the performances of the right ventricular autothreshold algorithm ;
  • Reporting the adverse events documented in the study;
  • Reporting electrical performances of Sorin Group PARADYM ICD, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
  • Reporting the Sorin atrial SonR and Situs 2 MV left ventricular leads performances;
  • Reporting the SonR atrial lead mechanical handling.
  • Reporting all information from SonR sensor to validate the SonR data exploitation and the AVD/VVD optimization.
  • Reporting the Situs 2 MV LV lead mechanical handling.
  • Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.

Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.

Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Heart Failure
Device: CRT-SonR 9770
Active implantable defibrillator with capacity of cardiac resynchronization therapy
Other Name: 9770
Experimental: CRT-SonR 9770
Active implantable defibrillator with ability to cardiac resynchronization therapy
Intervention: Device: CRT-SonR 9770
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2012
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD
  • Implanted with atrial SonR lead
  • Signed and dated informed consent

Exclusion Criteria:

  • VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
  • VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
  • VF was caused by electrocution;
  • Incessant VT/VF;
  • Patient is unable to attend the scheduled follow-ups at the implanting centre;
  • Patient is already enrolled in another ongoing clinical study;
  • Patient is unable to understand the aim of the study and its procedure;
  • Patient refuses to cooperate;
  • Patient is unable or refuses to provide informed consent;
  • Patient is minor (less than 18-year old);
  • Patient is pregnant;
  • Patient has life expectancy of less than 1 year;
  • Patient is forfeiture of freedom or under guardianship.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
SonR Study - ITSY05
Not Provided
Not Provided
Not Provided
Principal Investigator: Christophe CL Leclercq, Ryhtmologist CHU Rennes
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP