Back to resultsClinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
CRT-SonR 9770
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead
Eligibility 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.
Sites / Locations
- Leclercq
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRT-SonR 9770
Arm Description
Active implantable defibrillator with ability to cardiac resynchronization therapy
Outcomes
Primary Outcome Measures
Evaluation of the SonR lead safety
Complication free rate of the SonR lead superior to 90 %
Secondary Outcome Measures
Incidence of adverse events
Any adverse will be documented thoughout the study and will be reported.
ICD electrical performances
Report all ICD electrical performances of the Paradym RF ICD
Evaluation of the SonR atrial lead performance
Report electrical performances and lead handling at implant
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.
Evaluation of the left ventricular lead performances
Report the electrical performances and lead mechanical handling at implant.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01169272
Brief Title
Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
Official Title
Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRT-SonR 9770
Arm Type
Experimental
Arm Description
Active implantable defibrillator with ability to cardiac resynchronization therapy
Intervention Type
Device
Intervention Name(s)
CRT-SonR 9770
Other Intervention Name(s)
9770
Intervention Description
Active implantable defibrillator with capacity of cardiac resynchronization therapy
Primary Outcome Measure Information:
Title
Evaluation of the SonR lead safety
Description
Complication free rate of the SonR lead superior to 90 %
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Any adverse will be documented thoughout the study and will be reported.
Time Frame
12 months
Title
ICD electrical performances
Description
Report all ICD electrical performances of the Paradym RF ICD
Time Frame
12 months
Title
Evaluation of the SonR atrial lead performance
Description
Report electrical performances and lead handling at implant
Time Frame
3 months
Title
Evaluation of the AV/VV delays optimization
Description
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.
Time Frame
3 months
Title
Evaluation of the left ventricular lead performances
Description
Report the electrical performances and lead mechanical handling at implant.
Time Frame
12 months
Title
Evaluation of the Remote Monitoring Solution
Description
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.
Time Frame
12 months
Title
Evaluation of the right ventricular autothreshold performances
Description
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe CL Leclercq, Ryhtmologist
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leclercq
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
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