Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
2020년 10월 19일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
950
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Utrecht, 네덜란드, 3582 KE
- Diakonessenhuis Utrecht
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Alabama
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Birmingham, Alabama, 미국, 35233
- University Hospital of Alabama at Birmingham
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Huntsville, Alabama, 미국, 35801
- Heart Center Research
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Arizona
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Phoenix, Arizona, 미국, 85016
- Arizona Arrhythmia Research Center
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Arkansas
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Little Rock, Arkansas, 미국, 72211
- Arkansas Heart Hospital
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Little Rock, Arkansas, 미국, 72205
- Baptist Health Medical Center
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Rogers, Arkansas, 미국, 72758
- Mercy Hospital Northwest Arkansas
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California
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Bakersfield, California, 미국, 93308
- Central Cardiology
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Burbank, California, 미국, 91505
- Raymond Schaerf, MD
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Concord, California, 미국, 94520
- John Muir Medical Center
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Fullerton, California, 미국, 92835
- St. Jude Hospital
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Glendale, California, 미국, 91206
- Glendale Adventist Medical Center
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La Jolla, California, 미국, 92037
- Scripps Green Hospital
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Modesto, California, 미국, 95355
- Memorial Medical Center
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Newport Beach, California, 미국, 92629
- Premier Cardiology, Inc / Hoag Hospital
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Rancho Mirage, California, 미국, 92270
- Desert Cardiology Consultants
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Sacramento, California, 미국, 95819
- Mercy General Hospital
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Sacramento, California, 미국, 95819
- Sutter Memorial Hospital
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Colorado
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Denver, Colorado, 미국, 80012
- Aurora Denver Cardiology Associates
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Littleton, Colorado, 미국, 80120
- South Denver Cardiology Associates PC
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Loveland, Colorado, 미국, 80538
- Medical Center of the Rockies
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Florida
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Atlantis, Florida, 미국, 33462
- Medical Specialists of the Palm Beaches
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Lakeland, Florida, 미국, 33647
- Watson Clinic Center
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Orlando, Florida, 미국, 32803
- Florida Hospital Orlando
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Orlando, Florida, 미국, 32806
- Orlando Health
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Rockledge, Florida, 미국, 32955
- Brevard Cardiovascular Research Associates
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Tallahassee, Florida, 미국, 32308
- Tallahassee Research Institute
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Tampa, Florida, 미국, 33606
- University of South Florida, Cardiovascular Services
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Georgia
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Athens, Georgia, 미국, 30606
- Athens Cardiology Group, PC
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Atlanta, Georgia, 미국, 30041
- Atlanta Heart Specialist
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Illinois
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Springfield, Illinois, 미국, 62701
- Prairie Education And Research Cooperative
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Kentucky
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Lexington, Kentucky, 미국, 40503
- Central Baptist Hospital
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Louisiana
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New Orleans, Louisiana, 미국, 70121
- Ochsner Medical Center
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Michigan
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Grand Rapids, Michigan, 미국, 49503
- Spectrum Health
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Lansing, Michigan, 미국, 48910
- Thoracic Cardio Healthcare Foundation
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Southfield, Michigan, 미국, 48075
- Providence Hospital
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Minnesota
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Minneapolis, Minnesota, 미국, 55407
- Minneapolis Heart Institute
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Missouri
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Kansas City, Missouri, 미국, 64111
- St. Luke's Hospital
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, 미국, 63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha, Nebraska, 미국, 68124
- Alegent Creighton Health
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New York
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Rochester, New York, 미국, 14450
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7075
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, 미국, 28204
- Mid Carolina Cardiology
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Winston-Salem, North Carolina, 미국, 27615
- Wake Forest University Medical Center Clinical Sciences
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Ohio
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Cleveland, Ohio, 미국, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, 미국, 43210
- The Ohio State University
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Columbus, Ohio, 미국, 43213
- Columbus Cardiovascular Associates
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Elyria, Ohio, 미국, 44035
- EMH Regional Medical Center
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Youngstown, Ohio, 미국, 44501
- St. Elizabeth Health Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Integris Baptist Medical Center
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Tulsa, Oklahoma, 미국, 73112
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Abington, Pennsylvania, 미국, 72758
- Abington Medical Specialists
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Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny Singer Research Institute
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Sayre, Pennsylvania, 미국, 18840
- Donald Guthrie Foundation for Education and Research
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York, Pennsylvania, 미국, 17403
- York Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29401
- Medical University of South Carolina
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Charleston, South Carolina, 미국, 29406
- PMG Research of Charleston, LLC
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Texas
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Austin, Texas, 미국, 78756
- Austin Heart
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San Antonio, Texas, 미국, 78201
- South Texas Cardiovascular Consultants
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Temple, Texas, 미국, 76508
- Scott & White Memorial Hospital
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Virginia
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Charlottesville, Virginia, 미국, 22911
- Martha Jefferson Hospital
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Manassas, Virginia, 미국, 20109
- Virginia Cardiovascular Associates, PC
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Norfolk, Virginia, 미국, 23507
- Sentara Norfolk General Hospital
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Washington
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Bremerton, Washington, 미국, 98310
- Kitsap Cardiology Consultants
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Seattle, Washington, 미국, 98101
- The Heart Institute at Virginia Mason
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Wisconsin
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Milwaukee, Wisconsin, 미국, 14450
- Aurora Medical Group
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B Cap R
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Brussels, B Cap R, 벨기에, 1200
- Cliniques Universitaires Saint Luc
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East Finland
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Kuopio, East Finland, 핀란드, 70211
- Kuopio University Hospital
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South Australia
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Adelaide, South Australia, 호주, 5000
- St. Andrews Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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실험적: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Freedom From System-related Complications
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Grant Kim, Abbott Medical Devices
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 3월 30일
기본 완료 (실제)
2018년 2월 2일
연구 완료 (실제)
2018년 2월 2일
연구 등록 날짜
최초 제출
2012년 4월 4일
QC 기준을 충족하는 최초 제출
2012년 4월 10일
처음 게시됨 (추정)
2012년 4월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 10월 19일
마지막으로 확인됨
2020년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Accent MRI system (lead safety)에 대한 임상 시험
-
National Institute of Mental Health (NIMH)빼는
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National Heart, Lung, and Blood Institute (NHLBI)George Washington University모병