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BradycardiaBrady MRI PASNCT03170583

SJM Brady MRI Post Approval Study

An observational study of Bradycardia, run by Abbott Medical Devices at 66 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bradycardia
What is being tested?
St. Jude Medical Tendril MRI™ lead
Type of treatment
Medical device
How many people
1,768 participants
Where
66 sitesUnited States
Study dates
8 Jun 2017to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with a standard bradycardia indication.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 19001

  • Capital Cardiology Associates

    Albany, New York, 12211

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606

  • Medical Specialists of the Palm Beaches

    Atlantis, Florida, 33462

  • McLaren Health Care Corporation

    Auburn Hills, Michigan, 48326

  • Central Cardiology

    Bakersfield, California, 93308

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Bay Area Cardiology Associates PA

    Brandon, Florida, 33511

  • Raymond Schaerf, MD

    Burbank, California, 91505

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Novant Health Heart and Vascular Research Institute

    Charlotte, North Carolina, 28204

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Cheyenne Cardiology Associates

    Cheyenne, Wyoming, 82001

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • BCS Heart, LLP

    College Station, Texas, 77845

  • Missouri Heart Center

    Columbia, Missouri, 65201

  • Ohio State University

    Columbus, Ohio, 43210

  • Atlanta Heart Specialist

    Cumming, Georgia, 30041

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • St. Helena Hospital

    Deer Park, California, 94576

  • Fort Worth Heart

    Fort Worth, Texas, 76104

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • East Carolina Heart Institute

    Greenville, North Carolina, 27834

  • St. Francis Hospital

    Greenville, South Carolina, 29601

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Pinnacle Health System

    Harrisburg, Pennsylvania, 17105

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Houston Cardiovascular Associates

    Houston, Texas, 77030

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • Shands Jacksonville

    Jacksonville, Florida, 32209

  • Cardiology Associates of North East Arkansas

    Jonesboro, Arkansas, 72401

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Kearney Regional Medical Center

    Kearney, Nebraska, 68845

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • University of Kentucky

    Lexington, Kentucky, 40636

  • BryanLGH Medical Center East

    Lincoln, Nebraska, 68506

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • USC University Hospital

    Los Angeles, California, 90033

  • Coliseum Medical Centers

    Macon, Georgia, 31217

  • Carient Heart & Vascular, P.C.

    Manassas, Virginia, 20109

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • MidMichigan Medical Center-Midland

    Midland, Michigan, 48670

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53204

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • Hudson Valley Cardiovascular Practice, P.C.

    Poughkeepsie, New York, 12601

  • Riverside Medical Clinic

    Riverside, California, 92506

  • Mercy Hospital Northwest Arkansas

    Rogers, Arkansas, 72758

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • San Diego Heart Rhythm Center

    San Diego, California, 92103

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California, 92103

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania, 18840

  • New Brunswick Cardiology Group

    Somerset, New Jersey, 008873

  • Hrachian Hakop MD PA

    South Miami, Florida, 33143

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Cardiology Partners

    Wellington, Florida, 33449

Other trials in United States

About this study

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.

Read the 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.

Conditions
Bradycardia
Being tested
St. Jude Medical Tendril MRI™ lead
Keywords
bradycardia, pacemaker, MRI scan
Medical subject headings
Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • St. Jude Medical Tendril MRI™ leadDevice

    Also called St. Jude Medical Accent MRI™ pacemaker, St. Jude Medical Assurity MRI™ pacemaker, St. Jude Medical Endurity MRI™pacemaker

    pacemaker, leads

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from Tendril MRI RA lead-related complications through 60 months of follow up

    Measured: 60 months

  2. Freedom from Tendril MRI RV lead-related complications through 60 months of follow up

    Measured: 60 months

  3. MRI scan related complications rate through one-month following the MRI scan

    Measured: 1 month

Secondary outcomes (1)

  1. The complication rate of the Tendril MRI lead

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2017
  2. Study start8 Jun 2017
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Why it stopped: Abbott received FDA approval to transition the ongoing Brady MRI PAS study to EP a new EP-Passion Real World Evidence methodology

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,768 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03170583
Sponsor's protocol ID
SJM-CIP- CL1000304
Acronym
Brady MRI PAS
Status last verified
Jul 2020
First submitted
26 May 2017
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Bradycardia, run by Abbott Medical Devices at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Abbott received FDA approval to transition the ongoing Brady MRI PAS study to EP a new EP-Passion Real World Evidence methodology). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Tendril MRI RA lead-related complications through 60 months of follow up (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03170583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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