Abbott Brady 3T MRI PMCF

Study Overview
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Brief Summary
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The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

Detailed Description
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This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.

Official Title
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Long Term Follow-up of the Tendril STS and Isoflex Leads in Conjunction With the Assurity MRI™ and Endurity MRI™ Pacemakers Within the 3T MRI Environment (Brady 3T MRI PMCF)

Conditions
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Syncope, Presyncope, Fatigue, Disorientation, Arrythmia, Bradycardia

Intervention / Treatment
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* Radiation: 3T MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable). Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex 1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker. Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrollment. Subject is clinically indicated for a 3T MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Exclusion Criteria: The subject is currently participating in a clinical investigation that includes an active treatment arm that may confound the results of this study as determined by Abbott. The subject is <18 years old (pediatric). That subject has a life expectancy of less than 12 months due to any condition. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. Any contraindication to MRI scan, including the presence of additional hardware (e.g. lead extenders, lead adapters, surgical staples, stents, dental braces, or abandoned leads).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study. | Radiation: 3T MRI scan<br>* A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width |  | from pre- MRI scan to one-month post MRI scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan |  | from pre-MRI scan to one-month post-MRI scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3 Tesla MRI