Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SJM Brady MRI Post Approval Study (Brady MRI PAS)

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: NCT03170583
Recruitment Status : Terminated (Abbott received FDA approval to transition the ongoing Brady MRI PAS study to EP a new EP-Passion Real World Evidence methodology)
First Posted : May 31, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date May 26, 2017
First Posted Date May 31, 2017
Last Update Posted Date July 28, 2020
Actual Study Start Date June 8, 2017
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2017)
  • Freedom from Tendril MRI RA lead-related complications through 60 months of follow up [ Time Frame: 60 months ]
  • Freedom from Tendril MRI RV lead-related complications through 60 months of follow up [ Time Frame: 60 months ]
  • MRI scan related complications rate through one-month following the MRI scan [ Time Frame: 1 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2017)
The complication rate of the Tendril MRI lead [ Time Frame: 60 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SJM Brady MRI Post Approval Study
Official Title SJM Brady MRI Post Approval Study
Brief Summary 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

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with a standard bradycardia indication.
Condition Bradycardia
Intervention Device: St. Jude Medical Tendril MRI™ lead
pacemaker, leads
Other Names:
  • St. Jude Medical Accent MRI™ pacemaker
  • St. Jude Medical Assurity MRI™ pacemaker
  • St. Jude Medical Endurity MRI™pacemaker
Study Groups/Cohorts Not Provided
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 Terminated
Actual Enrollment
 (submitted: July 24, 2020)
1768
Original Estimated Enrollment
 (submitted: May 26, 2017)
1756
Actual Study Completion Date June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable).
  2. Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.
  3. Subject meets at least one of the following criteria:

    1. 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.
    2. 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.
    3. 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.
  4. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.

Exclusion Criteria:

  1. 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.
  2. 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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03170583
Other Study ID Numbers SJM-CIP- CL1000304
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: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Director: Grant Kim, MS Abbott (formerly St. Jude Medical)
PRS Account Abbott Medical Devices
Verification Date July 2020