Clinical trial NCT03170583: SJM Brady MRI Post Approval Study
Official title: SJM Brady MRI Post Approval Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bradycardia
Keywords: bradycardia, pacemaker, MRI scan
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 1768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a standard bradycardia indication.

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.

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.

Primary outcomes:
measure: Freedom from Tendril MRI RA lead-related complications through 60 months of follow up
timeFrame: 60 months
measure: Freedom from Tendril MRI RV lead-related complications through 60 months of follow up
timeFrame: 60 months
measure: MRI scan related complications rate through one-month following the MRI scan
timeFrame: 1 month
Secondary outcomes:
measure: The complication rate of the Tendril MRI lead
timeFrame: 60 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of North East Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Rogers
country: United States
facility: Mercy Hospital Northwest Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: Central Cardiology
state: California
city: Burbank
country: United States
facility: Raymond Schaerf, MD
state: California
city: Deer Park
country: United States
facility: St. Helena Hospital
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Riverside
country: United States
facility: Riverside Medical Clinic
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: San Diego
country: United States
facility: San Diego Heart Rhythm Center
state: California
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Brandon
country: United States
facility: Bay Area Cardiology Associates PA
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville
state: Florida
city: South Miami
country: United States
facility: Hrachian Hakop MD PA
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Cumming
country: United States
facility: Atlanta Heart Specialist
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Centers
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Auburn Hills
country: United States
facility: McLaren Health Care Corporation
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center-Midland
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Columbia
country: United States
facility: Missouri Heart Center
state: Missouri
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Kearney
country: United States
facility: Kearney Regional Medical Center
state: Nebraska
city: Lincoln
country: United States
facility: BryanLGH Medical Center East
state: Nebraska
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Somerset
country: United States
facility: New Brunswick Cardiology Group
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Cardiovascular Practice, P.C.
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Research Institute
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Heart Institute
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Abington
country: United States
facility: Abington Medical Specialists
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Hospital
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: College Station
country: United States
facility: BCS Heart, LLP
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Fort Worth
country: United States
facility: Fort Worth Heart
state: Texas
city: Houston
country: United States
facility: Houston Cardiovascular Associates
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Manassas
country: United States
facility: Carient Heart & Vascular, P.C.
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Cardiology Associates
state: Wyoming
Study officials:
affiliation: Abbott (formerly St. Jude Medical)
name: Grant Kim, MS
role: STUDY_DIRECTOR
References: