Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
19 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
950
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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South Australia
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Adelaide, South Australia, Australie, 5000
- St. Andrews Hospital
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B Cap R
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Brussels, B Cap R, Belgique, 1200
- Cliniques Universitaires Saint Luc
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East Finland
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Kuopio, East Finland, Finlande, 70211
- Kuopio University Hospital
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Utrecht, Pays-Bas, 3582 KE
- Diakonessenhuis Utrecht
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University Hospital of Alabama at Birmingham
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Huntsville, Alabama, États-Unis, 35801
- Heart Center Research
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Arizona
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Phoenix, Arizona, États-Unis, 85016
- Arizona Arrhythmia Research Center
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Arkansas
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Little Rock, Arkansas, États-Unis, 72211
- Arkansas Heart Hospital
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Little Rock, Arkansas, États-Unis, 72205
- Baptist Health Medical Center
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Rogers, Arkansas, États-Unis, 72758
- Mercy Hospital Northwest Arkansas
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California
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Bakersfield, California, États-Unis, 93308
- Central Cardiology
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Burbank, California, États-Unis, 91505
- Raymond Schaerf, MD
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Concord, California, États-Unis, 94520
- John Muir Medical Center
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Fullerton, California, États-Unis, 92835
- St. Jude Hospital
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Glendale, California, États-Unis, 91206
- Glendale Adventist Medical Center
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La Jolla, California, États-Unis, 92037
- Scripps Green Hospital
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Modesto, California, États-Unis, 95355
- Memorial Medical Center
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Newport Beach, California, États-Unis, 92629
- Premier Cardiology, Inc / Hoag Hospital
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Rancho Mirage, California, États-Unis, 92270
- Desert Cardiology Consultants
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Sacramento, California, États-Unis, 95819
- Mercy General Hospital
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Sacramento, California, États-Unis, 95819
- Sutter Memorial Hospital
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Colorado
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Denver, Colorado, États-Unis, 80012
- Aurora Denver Cardiology Associates
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Littleton, Colorado, États-Unis, 80120
- South Denver Cardiology Associates PC
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Loveland, Colorado, États-Unis, 80538
- Medical Center of the Rockies
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Florida
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Atlantis, Florida, États-Unis, 33462
- Medical Specialists of the Palm Beaches
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Lakeland, Florida, États-Unis, 33647
- Watson Clinic Center
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Orlando, Florida, États-Unis, 32803
- Florida Hospital Orlando
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Orlando, Florida, États-Unis, 32806
- Orlando Health
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Rockledge, Florida, États-Unis, 32955
- Brevard Cardiovascular Research Associates
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Tallahassee, Florida, États-Unis, 32308
- Tallahassee Research Institute
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Tampa, Florida, États-Unis, 33606
- University of South Florida, Cardiovascular Services
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Georgia
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Athens, Georgia, États-Unis, 30606
- Athens Cardiology Group, PC
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Atlanta, Georgia, États-Unis, 30041
- Atlanta Heart Specialist
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Illinois
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Springfield, Illinois, États-Unis, 62701
- Prairie Education And Research Cooperative
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Kentucky
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Lexington, Kentucky, États-Unis, 40503
- Central Baptist Hospital
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Medical Center
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Michigan
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Grand Rapids, Michigan, États-Unis, 49503
- Spectrum Health
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Lansing, Michigan, États-Unis, 48910
- Thoracic Cardio Healthcare Foundation
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Southfield, Michigan, États-Unis, 48075
- Providence Hospital
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55407
- Minneapolis Heart Institute
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Missouri
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Kansas City, Missouri, États-Unis, 64111
- St. Luke's Hospital
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Saint Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, États-Unis, 63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha, Nebraska, États-Unis, 68124
- Alegent Creighton Health
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New York
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Rochester, New York, États-Unis, 14450
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7075
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, États-Unis, 28204
- Mid Carolina Cardiology
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Winston-Salem, North Carolina, États-Unis, 27615
- Wake Forest University Medical Center Clinical Sciences
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, États-Unis, 43210
- The Ohio State University
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Columbus, Ohio, États-Unis, 43213
- Columbus Cardiovascular Associates
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Elyria, Ohio, États-Unis, 44035
- EMH Regional Medical Center
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Youngstown, Ohio, États-Unis, 44501
- St. Elizabeth Health Center
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73112
- Integris Baptist Medical Center
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Tulsa, Oklahoma, États-Unis, 73112
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Abington, Pennsylvania, États-Unis, 72758
- Abington Medical Specialists
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Pittsburgh, Pennsylvania, États-Unis, 15212
- Allegheny Singer Research Institute
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Sayre, Pennsylvania, États-Unis, 18840
- Donald Guthrie Foundation for Education and Research
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York, Pennsylvania, États-Unis, 17403
- York Hospital
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South Carolina
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Charleston, South Carolina, États-Unis, 29401
- Medical University of South Carolina
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Charleston, South Carolina, États-Unis, 29406
- PMG Research of Charleston, LLC
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Texas
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Austin, Texas, États-Unis, 78756
- Austin Heart
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San Antonio, Texas, États-Unis, 78201
- South Texas Cardiovascular Consultants
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Temple, Texas, États-Unis, 76508
- Scott & White Memorial Hospital
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Virginia
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Charlottesville, Virginia, États-Unis, 22911
- Martha Jefferson Hospital
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Manassas, Virginia, États-Unis, 20109
- Virginia Cardiovascular Associates, PC
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Norfolk, Virginia, États-Unis, 23507
- Sentara Norfolk General Hospital
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Washington
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Bremerton, Washington, États-Unis, 98310
- Kitsap Cardiology Consultants
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Seattle, Washington, États-Unis, 98101
- The Heart Institute at Virginia Mason
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 14450
- Aurora Medical Group
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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
Autres noms:
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Expérimental: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Freedom From System-related Complications
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Grant Kim, Abbott Medical Devices
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 mars 2012
Achèvement primaire (Réel)
2 février 2018
Achèvement de l'étude (Réel)
2 février 2018
Dates d'inscription aux études
Première soumission
4 avril 2012
Première soumission répondant aux critères de contrôle qualité
10 avril 2012
Première publication (Estimation)
12 avril 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 60028820
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .