Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
2020年10月19日 更新者：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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
950
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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B Cap R
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Brussels、B Cap R、比利时、1200
- Cliniques Universitaires Saint Luc
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South Australia
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Adelaide、South Australia、澳大利亚、5000
- St. Andrews Hospital
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Alabama
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Birmingham、Alabama、美国、35233
- University Hospital of Alabama at Birmingham
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Huntsville、Alabama、美国、35801
- Heart Center Research
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Arizona
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Phoenix、Arizona、美国、85016
- Arizona Arrhythmia Research Center
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Arkansas
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Little Rock、Arkansas、美国、72211
- Arkansas Heart Hospital
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Little Rock、Arkansas、美国、72205
- Baptist Health Medical Center
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Rogers、Arkansas、美国、72758
- Mercy Hospital Northwest Arkansas
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California
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Bakersfield、California、美国、93308
- Central Cardiology
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Burbank、California、美国、91505
- Raymond Schaerf, MD
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Concord、California、美国、94520
- John Muir Medical Center
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Fullerton、California、美国、92835
- St. Jude Hospital
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Glendale、California、美国、91206
- Glendale Adventist Medical Center
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La Jolla、California、美国、92037
- Scripps Green Hospital
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Modesto、California、美国、95355
- Memorial Medical Center
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Newport Beach、California、美国、92629
- Premier Cardiology, Inc / Hoag Hospital
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Rancho Mirage、California、美国、92270
- Desert Cardiology Consultants
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Sacramento、California、美国、95819
- Mercy General Hospital
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Sacramento、California、美国、95819
- Sutter Memorial Hospital
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Colorado
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Denver、Colorado、美国、80012
- Aurora Denver Cardiology Associates
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Littleton、Colorado、美国、80120
- South Denver Cardiology Associates PC
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Loveland、Colorado、美国、80538
- Medical Center of the Rockies
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Florida
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Atlantis、Florida、美国、33462
- Medical Specialists of the Palm Beaches
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Lakeland、Florida、美国、33647
- Watson Clinic Center
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Orlando、Florida、美国、32803
- Florida Hospital Orlando
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Orlando、Florida、美国、32806
- Orlando Health
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Rockledge、Florida、美国、32955
- Brevard Cardiovascular Research Associates
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Tallahassee、Florida、美国、32308
- Tallahassee Research Institute
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Tampa、Florida、美国、33606
- University of South Florida, Cardiovascular Services
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Georgia
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Athens、Georgia、美国、30606
- Athens Cardiology Group, PC
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Atlanta、Georgia、美国、30041
- Atlanta Heart Specialist
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Illinois
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Springfield、Illinois、美国、62701
- Prairie Education And Research Cooperative
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Kentucky
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Lexington、Kentucky、美国、40503
- Central Baptist Hospital
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Louisiana
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New Orleans、Louisiana、美国、70121
- Ochsner Medical Center
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Michigan
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Grand Rapids、Michigan、美国、49503
- Spectrum Health
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Lansing、Michigan、美国、48910
- Thoracic Cardio Healthcare Foundation
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Southfield、Michigan、美国、48075
- Providence Hospital
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Minnesota
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Minneapolis、Minnesota、美国、55407
- Minneapolis Heart Institute
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Missouri
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Kansas City、Missouri、美国、64111
- St. Luke's Hospital
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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Saint Louis、Missouri、美国、63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha、Nebraska、美国、68124
- Alegent Creighton Health
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New York
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Rochester、New York、美国、14450
- University of Rochester Medical Center
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7075
- University Of North Carolina At Chapel Hill
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Charlotte、North Carolina、美国、28204
- Mid Carolina Cardiology
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Winston-Salem、North Carolina、美国、27615
- Wake Forest University Medical Center Clinical Sciences
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Ohio
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Cleveland、Ohio、美国、44195
- The Cleveland Clinic Foundation
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Columbus、Ohio、美国、43210
- The Ohio State University
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Columbus、Ohio、美国、43213
- Columbus Cardiovascular Associates
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Elyria、Ohio、美国、44035
- EMH Regional Medical Center
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Youngstown、Ohio、美国、44501
- St. Elizabeth Health Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73112
- Integris Baptist Medical Center
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Tulsa、Oklahoma、美国、73112
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Abington、Pennsylvania、美国、72758
- Abington Medical Specialists
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny Singer Research Institute
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Sayre、Pennsylvania、美国、18840
- Donald Guthrie Foundation for Education and Research
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York、Pennsylvania、美国、17403
- York Hospital
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South Carolina
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Charleston、South Carolina、美国、29401
- Medical University of South Carolina
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Charleston、South Carolina、美国、29406
- PMG Research of Charleston, LLC
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Texas
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Austin、Texas、美国、78756
- Austin Heart
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San Antonio、Texas、美国、78201
- South Texas Cardiovascular Consultants
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Temple、Texas、美国、76508
- Scott & White Memorial Hospital
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Virginia
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Charlottesville、Virginia、美国、22911
- Martha Jefferson Hospital
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Manassas、Virginia、美国、20109
- Virginia Cardiovascular Associates, PC
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Norfolk、Virginia、美国、23507
- Sentara Norfolk General Hospital
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Washington
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Bremerton、Washington、美国、98310
- Kitsap Cardiology Consultants
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Seattle、Washington、美国、98101
- The Heart Institute at Virginia Mason
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Wisconsin
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Milwaukee、Wisconsin、美国、14450
- Aurora Medical Group
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East Finland
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Kuopio、East Finland、芬兰、70211
- Kuopio University Hospital
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Utrecht、荷兰、3582 KE
- Diakonessenhuis Utrecht
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lead Safety
Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
|
Patients implanted with an Accent MRI system
其他名称：
|
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实验性的：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
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
大体时间：Implant through 2 months
|
Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
|
Implant through 2 months
|
|
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
大体时间：Implant through 2 months
|
Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
|
Implant through 2 months
|
|
Freedom From RA Related Complications in the Chronic Period
大体时间：2 months through 12 months
|
Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
|
2 months through 12 months
|
|
Freedom From Right Ventricular Lead Related Complications in the Chronic Period
大体时间：2 months through 12 months
|
Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
|
2 months through 12 months
|
|
Freedom From MRI Scan-related Complications
大体时间：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
大体时间：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
|
|
Change in Ventricular Capture Threshold Pre to Post MRI Scan
大体时间：MRI Scan visit to 1 month after MRI scan visit
|
Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms.
|
MRI Scan visit to 1 month after MRI scan visit
|
|
Change in Atrial Sense Amplitude
大体时间：MRI Scan visit to 1 month after MRI scan visit
|
Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.
|
MRI Scan visit to 1 month after MRI scan visit
|
|
Change in Ventricular Sense Amplitude
大体时间：MRI Scan visit to 1 month after the MRI Scan visit
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Freedom From System-related Complications
大体时间：Implant through 12 months
|
Percentage of patients who do not have system-related complications from implant through the 12 month study visit
|
Implant through 12 months
|
|
Atrial Capture Threshold at the MRI Visit
大体时间：MRI Scan visit (approx 3 months post implant)
|
Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit
|
MRI Scan visit (approx 3 months post implant)
|
|
Ventricular Capture Threshold at the MRI Visit
大体时间：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)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Grant Kim、Abbott Medical Devices
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年3月30日
初级完成 (实际的)
2018年2月2日
研究完成 (实际的)
2018年2月2日
研究注册日期
首次提交
2012年4月4日
首先提交符合 QC 标准的
2012年4月10日
首次发布 (估计)
2012年4月12日
研究记录更新
最后更新发布 (实际的)
2020年11月10日
上次提交的符合 QC 标准的更新
2020年10月19日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.