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Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01169272
First received: July 20, 2010
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: CRT-SonR 9770
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Evaluation of the SonR lead safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Complication free rate of the SonR lead superior to 90 %


Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any adverse will be documented thoughout the study and will be reported.

  • ICD electrical performances [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Report all ICD electrical performances of the Paradym RF ICD

  • Evaluation of the SonR atrial lead performance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Report electrical performances and lead handling at implant

  • Evaluation of the AV/VV delays optimization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Report the electrical performances and lead mechanical handling at implant.

  • Evaluation of the Remote Monitoring Solution [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V.


Enrollment: 100
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRT-SonR 9770
Active implantable defibrillator with ability to cardiac resynchronization therapy
Device: CRT-SonR 9770
Active implantable defibrillator with capacity of cardiac resynchronization therapy
Other Name: 9770

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169272

Locations
France
Leclercq
Rennes, France, 35033
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Christophe CL Leclercq, Ryhtmologist CHU Rennes
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01169272     History of Changes
Other Study ID Numbers: SonR Study - ITSY05
Study First Received: July 20, 2010
Last Updated: June 17, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health

Keywords provided by Sorin Group:
ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014