Back to resultsClinical Evaluation Of The PARADYM RF Device
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
VR 9250 / DR 9550 / CRT 9750
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring ICD VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD
Eligibility Criteria
Inclusion Criteria:
- In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
- In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
- In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;
Exclusion Criteria:
- 1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
- 2 VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
- 3 VF was caused by electrocution;
- 4 Incessant VT/VF ;
- 5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
- 6 Patient is unable to attend the scheduled follow-ups at the implanting centre;
- 7 Patient is already enrolled in another ongoing clinical study;
- 8 Patient is unable to understand the aim of the study and its procedure;
- 9 Patient refuses to cooperate;
- 10 Patient is unable or refuses to provide informed consent;
- 11 Patient is minor (less than 18-year old);
- 12 Patient is pregnant;
- 13 Patient has life expectancy of less than 1 year;
- 14 Patient is forfeiture of freedom or under guardianship.
Sites / Locations
- Sack
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paradym RF ICD
Arm Description
Active implantable defibrillators range
Outcomes
Primary Outcome Measures
Demonstration of the Right ventricular (RV) autothreshold algorithm performances
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.
Secondary Outcome Measures
Incidence of adverse events
Any adverse event will be documented throughout the study and will be reported.
ICD electrical performances
Report all ICD electrical performances of the Paradym RF ICD.
Evaluation of the left ventricular lead performances
Report the electrical performances and lead mechanical handling at implant.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01193634
Brief Title
Clinical Evaluation Of The PARADYM RF Device
Official Title
Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 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
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.
Detailed Description
In the PARADYM RF clinical study, the sponsor aims at:
Demonstrating the performances of the right ventricular autothreshold algorithm ;
Reporting the adverse events documented in the study;
Reporting electrical performances of Sorin Group PARADYM ICDs, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.
Reporting the Situs 2 MV left ventricular lead performances;
Reporting the Situs 2 MV LV lead mechanical handling.
Thus, this study intends to show that PARADYM RF ICDs 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 VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paradym RF ICD
Arm Type
Experimental
Arm Description
Active implantable defibrillators range
Intervention Type
Device
Intervention Name(s)
VR 9250 / DR 9550 / CRT 9750
Other Intervention Name(s)
9250 / 9550 / 9750
Intervention Description
Active implantable defibrillators range
Primary Outcome Measure Information:
Title
Demonstration of the Right ventricular (RV) autothreshold algorithm performances
Description
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Any adverse event will be documented throughout 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 left ventricular lead performances
Description
Report the electrical performances and lead mechanical handling at implant.
Time Frame
12 months
Title
Evlauation of the Remote Monitoring Solution
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;
Exclusion Criteria:
1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
2 VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
3 VF was caused by electrocution;
4 Incessant VT/VF ;
5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
6 Patient is unable to attend the scheduled follow-ups at the implanting centre;
7 Patient is already enrolled in another ongoing clinical study;
8 Patient is unable to understand the aim of the study and its procedure;
9 Patient refuses to cooperate;
10 Patient is unable or refuses to provide informed consent;
11 Patient is minor (less than 18-year old);
12 Patient is pregnant;
13 Patient has life expectancy of less than 1 year;
14 Patient is forfeiture of freedom or under guardianship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sack SS Stefan, Pr
Organizational Affiliation
Klinikum Schwabing München Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sack
City
München
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation Of The PARADYM RF Device
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