The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups: (1) an MRI at a Magnet Field Strength of 3-tesla, (2) a "Mixed-vendor" or a Same Vendor "Mixed-component" Platform at 1.5-tesla or 3-tesla, or (3) a System With an Abandoned, Epicardial, or Fractured Lead at 1.5-tesla.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 主要终点
- Troponin T levels
研究概览
简要总结
SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been published by the Heart Rhythm Society, and the Medicare National Coverage Determination (NCD) has been modified to provide coverage for these patients (CAG-00399R4). However, for patients with an abandoned, epicardial, or fractured cardiac lead or subcutaneous array, with a "mixed-vendor" or same-vendor "mixed-component" CIED, or those undergoing MRI at 3.0-tesla with a device not labelled as MRI-conditional (MRC) for use at 3-tesla, the risks of MRI have not been determined.
Hypothesis: For patients with an MRC or NMRC pacemaker or defibrillator and specific indications or circumstances not presently addressed, the risks of MRI do not increase.
Purpose: The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI.
Study Design: A prospective registry of patients undergoing clinically indicated MRI. The protocol is being developed in collaboration with the FDA's Center for Devices and Radiological Health, and an Investigational Device Exemption is being requested for event reporting and monitoring. Also, "Coverage with Evidence Development (CED)" has been requested from CMS.
Enrollment: Eligible patients are 18 years or older and have a MRC or NMRC pacemaker system from any manufacturer, (after 2001), with leads from any manufacturer (without date restriction), and if the ordering physician has determined that MRI is clinically indicated, the imaging method of choice, and NOT performed for the purpose of research. Exclusions are a leadless pacemaker, a device battery at "elective replacement indicator," or renal insufficiency (GFR <45 cc/min). All participants will be required to provide informed consent for the collection of data.
Methods: Patients will be enrolled in the registry at up to 30 clinical centers with: (1) an NMRC pacing system scheduled for MRI at a magnet field strength of 3-tesla, (2) an NMRC system due to a "mixed-vendor" or a same vendor "mixed-component" platform at 1.5-tesla or 3-tesla, or (3) an MRC or NMRC pacing system and an abandoned, epicardial, or fractured lead at 1.5-tesla.
Primary Endpoints: A new cardiac arrhythmia noted during the MRI scan, or a Troponin-T elevation (>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI. Secondary Endpoints: Death, generator or lead failure requiring immediate replacement, loss of pacing capture (pacing-dependent patients), partial or full generator-electrical reset, pacing lead threshold increase of ≥1.0 V, a P-wave amplitude decrease of ≥50%, an R-wave amplitude decrease of ≥50%, and a pacing lead impedance change of ≥50 ohms from baseline.
Sample Size: Using an event rate limit of ≤1%, 500 cases will be needed in each group to yield a 95% confidence interval of 0 to 1.0% if no events are observed. When a total of 500 cases have been enrolled in one group, enrollment in the other groups may be continued at the discretion of the investigators. The estimated study duration is 5 years, including enrollment and data analysis.
Clinical Implications and Impact: The anticipated results will support an amendment to the current HRS Expert Consensus Statement (2017) and Medicare NCD (April 2018) for the patient groups in the study.
详细描述
1. INTRODUCTION 1.1 Specific aims The specific aims of the MagnaSafe-2 registry are to document the risks of magnetic resonance imaging (MRI) at a scanner strength of 3-tesla for patients with a non-MRI-conditional (NMRC) pacing system, to document the risks of MRI at 1.5-tesla for patients with an abandoned lead, epicardial lead, fractured lead or subcutaneous array, and to document the risks of MRI at 1.5-tesla or 3-tesla for patients with a "mixed-vendor" or "mixed-component" Cardiovascular Implantable Electronic Devices (CIED) system. A "mixed-vendor" system is defined as a combination of leads and a generator, both labeled for use in the MRI environment but from different manufacturers, and as a result, considered NMRC. A "mixed-component" system is defined as leads and a generator from the same manufacturer but not labelled as MRC as a combined device.
The study is a prospective multicenter registry of patients undergoing clinically indicated MRI. We anticipate that the results of the MagnaSafe-2 registry will support a change in MRI access for the three patient groups that are not addressed in the current HRS Expert Consensus Statement on MRI in Patients with CIED (2017), and are not covered by the updated Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (CAG-000399R-4; April 2018).
1.2 Background and Significance Overall, 3 million people in the United States have a cardiac pacemaker or an implanted defibrillator, with approximately 600,000 being implanted each year. While CIED placement has increased, MRI has also become the imaging modality of choice for the evaluation of an increasing number of diseases of the brain, spinal cord, heart, and musculoskeletal system. Previous investigators have estimated that after placement of a pacemaker or a defibrillator, a patient will have a 50-75% chance of requiring a clinically indicated MRI study.
MRI was once believed to pose a risk for patients with a CIED, including a pacemaker, an implantable cardioverter defibrillator (ICD), or a cardiac resynchronization device. Most safety concerns regarding MRI were focused upon the potential of radiofrequency (RF) induced thermal injury at the interface of a cardiac lead and the distal myocardial implantation site in the right atrium, right ventricle, or coronary sinus. As a result of these safety concerns, it was long recommended that patients with a CIED should not undergo MRI scanning, even when MR was determined to be the most appropriate imaging modality for a specific clinical problem or anatomic location. To provide optimal care to the increasing number of patients with a CIED, health care professionals must have the capability to perform an MRI with full knowledge of the possible risks of the examination and have appropriate access to imaging for CIED patients.
1.3 MRI in Patients with Cardiac Devices Over the past two decades, CIED generator-plus-lead systems have been developed by many manufacturers to limit the potential risks associated with MRI. Device-plus-lead systems with a low or acceptable theoretical risk to the patient when used under specific conditions are labeled MRC by the US Food and Drug Administration (FDA) Center for Devices and Radiological Health in response to a manufacturer's request, accompanied by corroborating safety data. In February 2011, the first MRC pacemaker and lead system (Medtronic Revo MRI SureScan with 5086 leads) was approved by the FDA for scanning at an MR field strength of 1.5-tesla. Since that time, more than 50 pacemakers and defibrillator systems have received MRC labelling by the FDA Center for Devices and Radiological Health for use in the MR environment, and guideline documents have been published by several cardiovascular and radiological professional societies worldwide to address care for CIED patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the registry if they fulfill all the following criteria:
- •Age of 18 years or older
- •Able to provide informed consent for entry in the research registry
- •Have a CIED from any manufacturer implanted after 2001
- •Have cardiac leads from any manufacturer without an implant date limitation
- •Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology
- •The patient is scheduled for that imaging procedure
- •MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol
- •In addition, groups within the protocol require that an enrolled patient will have:
- •An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength.
- •A "mixed-vendor" or same vendor "mixed-component" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment.
- •A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array.
排除标准
- •Patients will not be included in the registry if they fulfill any of the following criteria:
- •A generator battery at the elective replacement indicator (ERI)
- •Renal insufficiency (GFR <45 cc/min)
- •In addition, all standard clinical exclusion criteria for MRI in patients without a cardiac device will be observed.
- •Standard clinical exclusion criteria include pregnancy, severe claustrophobia (not responsive to pre-procedure medications), morbid obesity (abdominal diameter of greater than 60 cm), and the presence of ferro-magnetic metallic objects (such as intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils)
结局指标
主要结局
Troponin T levels
时间窗: Baseline and 24 hours
Troponin-T elevation (\>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI.
次要结局
- Arrythmia(Periprocedural)
- Changes to pacemaker(Periprocedural)
- Heart function(Periprocedural)