SJM Brady MRI Post Approval Study

Bradycardia Clinical Trial

— Brady MRI PAS  

Official title:

SJM Brady MRI Post Approval Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03170583
• Other study ID #: SJM-CIP- CL1000304
• Status: Terminated
• Start date: June 8, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 standard bradycardia pacing indication.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1768
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• St. Jude Medical Tendril MRI™ lead
pacemaker, leads

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Tendril MRI RA lead-related complications through 60 months of follow up		60 months
Primary	Freedom from Tendril MRI RV lead-related complications through 60 months of follow up		60 months
Primary	MRI scan related complications rate through one-month following the MRI scan		1 month
Secondary	The complication rate of the Tendril MRI lead		60 months