Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
19 de octubre de 2020 actualizado por: Abbott Medical Devices
Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
950
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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South Australia
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Adelaide, South Australia, Australia, 5000
- St. Andrews Hospital
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B Cap R
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Brussels, B Cap R, Bélgica, 1200
- Cliniques Universitaires Saint Luc
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University Hospital of Alabama at Birmingham
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Huntsville, Alabama, Estados Unidos, 35801
- Heart Center Research
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
- Arizona Arrhythmia Research Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72211
- Arkansas Heart Hospital
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Little Rock, Arkansas, Estados Unidos, 72205
- Baptist Health Medical Center
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Rogers, Arkansas, Estados Unidos, 72758
- Mercy Hospital Northwest Arkansas
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California
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Bakersfield, California, Estados Unidos, 93308
- Central Cardiology
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Burbank, California, Estados Unidos, 91505
- Raymond Schaerf, MD
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Concord, California, Estados Unidos, 94520
- John Muir Medical Center
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Fullerton, California, Estados Unidos, 92835
- St. Jude Hospital
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Glendale, California, Estados Unidos, 91206
- Glendale Adventist Medical Center
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La Jolla, California, Estados Unidos, 92037
- Scripps Green Hospital
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Modesto, California, Estados Unidos, 95355
- Memorial Medical Center
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Newport Beach, California, Estados Unidos, 92629
- Premier Cardiology, Inc / Hoag Hospital
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Rancho Mirage, California, Estados Unidos, 92270
- Desert Cardiology Consultants
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Sacramento, California, Estados Unidos, 95819
- Mercy General Hospital
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Sacramento, California, Estados Unidos, 95819
- Sutter Memorial Hospital
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Colorado
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Denver, Colorado, Estados Unidos, 80012
- Aurora Denver Cardiology Associates
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Littleton, Colorado, Estados Unidos, 80120
- South Denver Cardiology Associates PC
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Loveland, Colorado, Estados Unidos, 80538
- Medical Center of the Rockies
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Florida
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Atlantis, Florida, Estados Unidos, 33462
- Medical Specialists of the Palm Beaches
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Lakeland, Florida, Estados Unidos, 33647
- Watson Clinic Center
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Orlando, Florida, Estados Unidos, 32803
- Florida Hospital Orlando
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Orlando, Florida, Estados Unidos, 32806
- Orlando Health
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Rockledge, Florida, Estados Unidos, 32955
- Brevard Cardiovascular Research Associates
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Tallahassee, Florida, Estados Unidos, 32308
- Tallahassee Research Institute
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida, Cardiovascular Services
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Georgia
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Athens, Georgia, Estados Unidos, 30606
- Athens Cardiology Group, PC
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Atlanta, Georgia, Estados Unidos, 30041
- Atlanta Heart Specialist
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Illinois
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Springfield, Illinois, Estados Unidos, 62701
- Prairie Education And Research Cooperative
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Central Baptist Hospital
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Medical Center
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- Spectrum Health
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Lansing, Michigan, Estados Unidos, 48910
- Thoracic Cardio Healthcare Foundation
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Southfield, Michigan, Estados Unidos, 48075
- Providence Hospital
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55407
- Minneapolis Heart Institute
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- St. Luke's Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68124
- Alegent Creighton Health
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New York
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Rochester, New York, Estados Unidos, 14450
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7075
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28204
- Mid Carolina Cardiology
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Winston-Salem, North Carolina, Estados Unidos, 27615
- Wake Forest University Medical Center Clinical Sciences
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University
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Columbus, Ohio, Estados Unidos, 43213
- Columbus Cardiovascular Associates
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Elyria, Ohio, Estados Unidos, 44035
- EMH Regional Medical Center
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Youngstown, Ohio, Estados Unidos, 44501
- St. Elizabeth Health Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Integris Baptist Medical Center
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Tulsa, Oklahoma, Estados Unidos, 73112
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 72758
- Abington Medical Specialists
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny Singer Research Institute
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Sayre, Pennsylvania, Estados Unidos, 18840
- Donald Guthrie Foundation for Education and Research
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York, Pennsylvania, Estados Unidos, 17403
- York Hospital
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29401
- Medical University of South Carolina
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Charleston, South Carolina, Estados Unidos, 29406
- PMG Research of Charleston, LLC
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Texas
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Austin, Texas, Estados Unidos, 78756
- Austin Heart
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San Antonio, Texas, Estados Unidos, 78201
- South Texas Cardiovascular Consultants
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Temple, Texas, Estados Unidos, 76508
- Scott & White Memorial Hospital
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22911
- Martha Jefferson Hospital
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Manassas, Virginia, Estados Unidos, 20109
- Virginia Cardiovascular Associates, PC
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Norfolk, Virginia, Estados Unidos, 23507
- Sentara Norfolk General Hospital
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Washington
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Bremerton, Washington, Estados Unidos, 98310
- Kitsap Cardiology Consultants
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Seattle, Washington, Estados Unidos, 98101
- The Heart Institute at Virginia Mason
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 14450
- Aurora Medical Group
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East Finland
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Kuopio, East Finland, Finlandia, 70211
- Kuopio University Hospital
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Utrecht, Países Bajos, 3582 KE
- Diakonessenhuis Utrecht
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Eligible patients will meet all of the following:
- Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker
- Will receive a new pacemaker and lead
- Be willing to undergo an elective MRI scan without sedation
- Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
- Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
- 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:
- Are medically indicated for an MRI scan at the time of enrollment
- Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new pacemaker and lead is required for enrollment
- Have an existing active/inactive implanted medical device, e.g., neurostimulator, infusion pump, etc.
- Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.)
- Have a lead extender or adaptor
- Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
- Have a prosthetic tricuspid heart valve
- Are currently participating in a clinical investigation that includes an active treatment arm
- Are allergic to dexamethasone sodium phosphate (DSP)
- Are pregnant or planning to become pregnant during the duration of the study
- Have a life expectancy of less than 12 months due to any condition
- Patients with exclusion criteria required by local law (e.g., age)
- Are unable to comply with the follow up schedule
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
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Patients implanted with an Accent MRI system
Otros nombres:
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Experimental: Accent MRI system MRI Scan Group
Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment
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Patients implanted with an Accent MRI system will receive an MRI scan
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Periodo de tiempo: Implant through 2 months
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Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
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Implant through 2 months
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Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
Periodo de tiempo: Implant through 2 months
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Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
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Implant through 2 months
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Freedom From RA Related Complications in the Chronic Period
Periodo de tiempo: 2 months through 12 months
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Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
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2 months through 12 months
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Freedom From Right Ventricular Lead Related Complications in the Chronic Period
Periodo de tiempo: 2 months through 12 months
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Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
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2 months through 12 months
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Freedom From MRI Scan-related Complications
Periodo de tiempo: MRI Scan visit through 1 month after MRI scan visit
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Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
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MRI Scan visit through 1 month after MRI scan visit
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Change in Atrial Capture Threshold From Pre to Post MRI Scan
Periodo de tiempo: MRI Scan visit to 1 month after MRI scan visit
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Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms .
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MRI Scan visit to 1 month after MRI scan visit
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Change in Ventricular Capture Threshold Pre to Post MRI Scan
Periodo de tiempo: MRI Scan visit to 1 month after MRI scan visit
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Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms.
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MRI Scan visit to 1 month after MRI scan visit
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Change in Atrial Sense Amplitude
Periodo de tiempo: MRI Scan visit to 1 month after MRI scan visit
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Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.
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MRI Scan visit to 1 month after MRI scan visit
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Change in Ventricular Sense Amplitude
Periodo de tiempo: MRI Scan visit to 1 month after the MRI Scan visit
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Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV.
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MRI Scan visit to 1 month after the MRI Scan visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Freedom From System-related Complications
Periodo de tiempo: Implant through 12 months
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Percentage of patients who do not have system-related complications from implant through the 12 month study visit
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Implant through 12 months
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Atrial Capture Threshold at the MRI Visit
Periodo de tiempo: MRI Scan visit (approx 3 months post implant)
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Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit
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MRI Scan visit (approx 3 months post implant)
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Ventricular Capture Threshold at the MRI Visit
Periodo de tiempo: MRI Scan visit (approx 3 months post implant)
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Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit
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MRI Scan visit (approx 3 months post implant)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Grant Kim, Abbott Medical Devices
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de marzo de 2012
Finalización primaria (Actual)
2 de febrero de 2018
Finalización del estudio (Actual)
2 de febrero de 2018
Fechas de registro del estudio
Enviado por primera vez
4 de abril de 2012
Primero enviado que cumplió con los criterios de control de calidad
10 de abril de 2012
Publicado por primera vez (Estimar)
12 de abril de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
19 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 60028820
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .