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Abbott Brady 3T MRI PMCF

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ClinicalTrials.gov Identifier: NCT03786640
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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 scan.

Condition or disease Intervention/treatment
Syncope Presyncope Fatigue Disorientation Arrythmia Bradycardia Radiation: 3T MRI scan

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single Arm
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
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.




Primary Outcome Measures :
  1. Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width [ Time Frame: from pre- MRI scan to one-month post MRI scan ]

Secondary Outcome Measures :
  1. Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan [ Time Frame: from pre-MRI scan to one-month post-MRI scan ]

Other Outcome Measures:
  1. MRI-related adverse events [ Time Frame: from pre- to 12-month post- MRI scan ]

    including but not limited to, the following:

    • Device (pulse generator) heating resulting in tissue damage in the implant pocket, or patient pocket discomfort, or both.
    • Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three.
    • Loss of pacing or capture in the MRI environment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any study procedures not considered standard of care.
Criteria

Inclusion Criteria:

  1. Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable).
  2. Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex 1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.
  3. Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrollment.
  4. 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
  5. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

  1. 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.
  2. The subject is <18 years old (pediatric).
  3. That subject has a life expectancy of less than 12 months due to any condition.
  4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
  5. 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.
  6. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786640


Contacts
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Contact: Michael Boogmans +3227746757 michael.boogmans@abbott.com

Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03786640     History of Changes
Other Study ID Numbers: ABT-CIP-10266
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abbott Medical Devices:
3 Tesla MRI

Additional relevant MeSH terms:
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Fatigue
Syncope
Bradycardia
Confusion
Signs and Symptoms
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes