Clinical trial NCT01576016: Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
Official title: Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect of MRI on an Implanted Pacemaker Lead
Adverse Effect of MRI on an Implanted Pacemaker
Keywords: bradycardia
MRI scans
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 950
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Detailed description: The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment.

The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below:

Lead Safety Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe).

MRI Safety The safety of the Accent MRI™ system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan.

Lead Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan.

MRI Efficacy Efficacy of the Tendril MR lead will be evaluated in terms of the change in bipolar atrial and ventricular capture and sensing thresholds before and after the MRI scan.

Secondary Endpoints Safety Safety of the Accent MRI™ system will be evaluated in terms of freedom from system-related complications through the 12 month visit.

Efficacy Efficacy of the Tendril MRI™ lead will be evaluated in terms of the atrial and ventricular capture thresholds at the MRI Visit.

Eligibility criteria: Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker
2. Will receive a new pacemaker and lead
3. Be willing to undergo an elective MRI scan without sedation
4. Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
5. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
6. Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Are medically indicated for an MRI scan at the time of enrollment
2. Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment
3. Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
5. Have a lead extender or adaptor
6. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
7. Have a prosthetic tricuspid heart valve
8. Are currently participating in a clinical investigation that includes an active treatment arm
9. Are allergic to dexamethasone sodium phosphate (DSP)
10. Are pregnant or planning to become pregnant during the duration of the study
11. Have a life expectancy of less than 12 months due to any condition
12. Patients with exclusion criteria required by local law (e.g., age)
13. Are unable to comply with the follow up schedule

Primary outcomes:
measure: Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
timeFrame: Implant through 2 months
measure: Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
timeFrame: Implant through 2 months
measure: Freedom From RA Related Complications in the Chronic Period
timeFrame: 2 months through 12 months
measure: Freedom From Right Ventricular Lead Related Complications in the Chronic Period
timeFrame: 2 months through 12 months
measure: Freedom From MRI Scan-related Complications
timeFrame: MRI Scan visit through 1 month after MRI scan visit
measure: Change in Atrial Capture Threshold From Pre to Post MRI Scan
timeFrame: MRI Scan visit to 1 month after MRI scan visit
measure: Change in Ventricular Capture Threshold Pre to Post MRI Scan
timeFrame: MRI Scan visit to 1 month after MRI scan visit
measure: Change in Atrial Sense Amplitude
timeFrame: MRI Scan visit to 1 month after MRI scan visit
measure: Change in Ventricular Sense Amplitude
timeFrame: MRI Scan visit to 1 month after the MRI Scan visit
Secondary outcomes:
measure: Freedom From System-related Complications
timeFrame: Implant through 12 months
measure: Atrial Capture Threshold at the MRI Visit
timeFrame: MRI Scan visit (approx 3 months post implant)
measure: Ventricular Capture Threshold at the MRI Visit
timeFrame: MRI Scan visit (approx 3 months post implant)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Medical Center
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: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology, Inc / Hoag Hospital
state: California
city: Rancho Mirage
country: United States
facility: Desert Cardiology Consultants
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: Denver
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Research Associates
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Cardiovascular Services
state: Florida
city: Athens
country: United States
facility: Athens Cardiology Group, PC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Heart Specialist
state: Georgia
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Lansing
country: United States
facility: Thoracic Cardio Healthcare Foundation
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Omaha
country: United States
facility: Alegent Creighton Health
state: Nebraska
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Medical Center Clinical Sciences
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Columbus Cardiovascular Associates
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Health Center
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Utica
state: Oklahoma
city: Abington
country: United States
facility: Abington Medical Specialists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Charlottesville
country: United States
facility: Martha Jefferson Hospital
state: Virginia
city: Manassas
country: United States
facility: Virginia Cardiovascular Associates, PC
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Bremerton
country: United States
facility: Kitsap Cardiology Consultants
state: Washington
city: Seattle
country: United States
facility: The Heart Institute at Virginia Mason
state: Washington
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Adelaide
country: Australia
facility: St. Andrews Hospital
state: South Australia
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
state: B Cap R
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: East Finland
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
Study officials:
affiliation: Abbott Medical Devices
name: Grant Kim
role: STUDY_DIRECTOR
References: