Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
19 de outubro de 2020 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
950
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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South Australia
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Adelaide, South Australia, Austrália, 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, Finlândia, 70211
- Kuopio University Hospital
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Utrecht, Holanda, 3582 KE
- Diakonessenhuis Utrecht
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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
Outros nomes:
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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
|
Patients implanted with an Accent MRI system will receive an MRI scan
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Prazo: 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
Prazo: 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
|
Implant through 2 months
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Freedom From RA Related Complications in the Chronic Period
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 .
|
MRI Scan visit to 1 month after MRI scan visit
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Change in Ventricular Capture Threshold Pre to Post MRI Scan
Prazo: 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
Prazo: 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
Prazo: 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.
|
MRI Scan visit to 1 month after the MRI Scan visit
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Freedom From System-related Complications
Prazo: Implant through 12 months
|
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
Prazo: 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
Prazo: MRI Scan visit (approx 3 months post implant)
|
Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit
|
MRI Scan visit (approx 3 months post implant)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Grant Kim, Abbott Medical Devices
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de março de 2012
Conclusão Primária (Real)
2 de fevereiro de 2018
Conclusão do estudo (Real)
2 de fevereiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
4 de abril de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de abril de 2012
Primeira postagem (Estimativa)
12 de abril de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 60028820
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .