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Clinical Evaluation Of The PARADYM RF Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Sorin Group.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01193634
First received: August 31, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Heart Failure
 Device: VR 9250 / DR 9550 / CRT 9750
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Demonstration of the Right ventricular (RV) autothreshold algorithm performances [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.


Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any adverse event will be documented throughout 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 left ventricular lead performances [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Report the electrical performances and lead mechanical handling at implant.

  • Evlauation of the Remote Monitoring Solution [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 72
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paradym RF ICD
Active implantable defibrillators range
 Device: VR 9250 / DR 9550 / CRT 9750
Active implantable defibrillators range
Other Name: 9250 / 9550 / 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193634

Locations
Germany
Sack Not yet recruiting
München, Germany, 80804
Contact: Sack SS Stefan, Pr     +49 89 3068-2525     stefan.sack@klinikum-muenchen.de    
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Sack SS Stefan, Pr Klinikum Schwabing München Germany
  More Information

No publications provided

Responsible Party: Pr Sack / Principal Investigator, Klinikum Schwabing Kölner Platz 1 80804 München GERMANY
ClinicalTrials.gov Identifier: NCT01193634     History of Changes
Other Study ID Numbers: ITSY03 - PARADYM RF STUDY
Study First Received: August 31, 2010
Last Updated: August 31, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
UK: National Health Service
Spain: Ministry of Health

Keywords provided by Sorin Group:
ICD VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013