Clinical Evaluation Of The PARADYM RF Device

Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: VR 9250 / DR 9550 / CRT 9750

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 80804
    • Sack

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paradym RF ICD; Active implantable defibrillators range	Device: VR 9250 / DR 9550 / CRT 9750; Active implantable defibrillators range; Other Names: 9250 / 9550 / 9750

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the left ventricular lead performances	Report the electrical performances and lead mechanical handling at implant.	12 months
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.	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

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Sack SS Stefan, Pr, Klinikum Schwabing München Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: ICD VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ITSY03 - PARADYM RF STUDY