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Trial record 2 of 4 for:    BRADY MRI

Abbott Brady 3T MRI PMCF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786640
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date December 20, 2018
First Posted Date December 26, 2018
Last Update Posted Date April 14, 2022
Actual Study Start Date October 4, 2019
Actual Primary Completion Date November 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2018)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2018)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2019)
Rate of 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.
Original Other Pre-specified Outcome Measures
 (submitted: December 20, 2018)
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.
 
Descriptive Information
Brief Title Abbott Brady 3T MRI PMCF
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)
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 (3 Tesla Magnetic Resonance Imaging) 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Syncope
  • Presyncope
  • Fatigue
  • Disorientation
  • Arrythmia
  • Bradycardia
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Radiation: 3T MRI scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2022)
3
Original Estimated Enrollment
 (submitted: December 20, 2018)
110
Actual Study Completion Date December 18, 2021
Actual Primary Completion Date November 18, 2021   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Estonia,   France,   India,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03786640
Other Study ID Numbers ABT-CIP-10266
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor Abbott Medical Devices
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date April 2022