SJM Brady MRI Post Approval Study

Study Overview
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Brief Summary
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The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.

Detailed Description
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This is a prospective, multi-center clinical study designed to evaluate the long-term safety of the Tendril MRI™ lead implanted with any SJM Brady MRI pacemaker or similar model (SJM Brady MRI system) in subjects with a standard bradycardia pacing indication through 60 months of follow up. Additionally, the study will assess the safety of the pacemaker system in subject(s) undergoing clinically indicated MRI scan(s). Any enrolled subject implanted with the SJM Brady MRI system may be included in this evaluation if they are scheduled for or planning to have a MRI scan during the course of the study.

Official Title
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SJM Brady MRI Post Approval Study

Conditions
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Bradycardia

Intervention / Treatment
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* Device: St. Jude Medical Tendril MRI™ lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable). Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law. Subject meets at least one of the following criteria: Is an Accent MRI IDE study subject who is being rolled over into the SJM Brady MRI PAS and still has at least one Tendril MRI™ lead implanted with a SJM Brady MRI pacemaker such as the Accent MRI or similar model. Is a subject who has been implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model, but is not part of the Accent MRI IDE study and will be enrolled within 30 days after implant. Is a subject who will be implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model and will be consented either at or within 30 days before implant. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures. Exclusion Criteria: Subject has been enrolled or intends to participate in a clinical drug and/or device study with an active treatment arm or that has any procedures, which could confound the results of this trial. Subject is not expected to be able to complete the study follow up schedule or duration due to any health condition such as has malignancy, is deemed a candidate for transplant or Ventricular Assist Device, or in hospice care.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: St. Jude Medical Tendril MRI™ lead|pacemaker, leads|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Tendril MRI RA lead-related complications through 60 months of follow up |  | 60 months | 
| Freedom from Tendril MRI RV lead-related complications through 60 months of follow up |  | 60 months | 
| MRI scan related complications rate through one-month following the MRI scan |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complication rate of the Tendril MRI lead |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bradycardia, pacemaker, MRI scan