Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Sorin Group.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01341522
First received: April 1, 2011
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement , which demonstrates the need of practical, safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing system is developed by Sorin Group for safe use in the MRI environment. The new pacing system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group Reply MR-conditional pacing system.
| Condition | Intervention | Phase |
|---|---|---|
|
Dual-chamber Pacemaker Placement |
Procedure: MRI exam Device: REPLY DR pacemaker and Filtrea leads |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System |
Further study details as provided by Sorin Group:
Primary Outcome Measures:
- assess the pacing system-, MRI- and implant procedure-related complication-free rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- assess atrial and ventricular lead-related complication-free rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Summarize all implant procedure, pacing system- and MRI procedure-related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Summarize atrial and ventricular electrical performances [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Summarize atrial and ventricular lead handling [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 103 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Control | Device: REPLY DR pacemaker and Filtrea leads |
| Experimental: MRI | Procedure: MRI exam Device: REPLY DR pacemaker and Filtrea leads |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who are candidates for dual-chamber pacemaker primo-implantation
- Patients who have indication for implantation of a dual-chamber pacemaker according to the American College of Cardiology and the American Heart Association
- Patients who are able and willing to undergo elective MRI scanning
- Patients who are scheduled for implant of a Reply DR pacemaker and Filtrea lead(s) only
- Patients who provided signed and dated informed consent
Exclusion Criteria:
- Non MR-compatible device or material implant
- Chronic atrial fibrillation (for atrial lead evaluation)
- Incessant ventricular tachyarrhythmia (for ventricular lead evaluation)
- Inability to understand the purpose of the study or refusal to co-operate
- Unavailability for scheduled follow-ups at the implanting centre
- Already included in another clinical study that could affect the results of this study
- Inability or refusal to provide informed consent
- Patient is minor (less than 18-year old)
- Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment);
- Patient has life expectancy of less than 1 year
- Patient is forfeiture of freedom or under guardianship
- Any patient to whom a contra-indication from device and lead labeling applies
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sorin CRM SAS / Sponsor, Parc d'Affaires NOVEOS 4 avenue Réaumur 92140 Clamart Cedex |
| ClinicalTrials.gov Identifier: | NCT01341522 History of Changes |
| Other Study ID Numbers: | IBMR01 - REPLY MRI STUDY |
| Study First Received: | April 1, 2011 |
| Last Updated: | April 22, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices UK : National Health Service Italy: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Ministry of Health |
ClinicalTrials.gov processed this record on June 18, 2013