Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
研究概览
详细说明
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.
A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.
All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Alabama
-
Huntsville、Alabama、美国、35801
- Heart Center Research
-
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Arizona
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Phoenix、Arizona、美国、85013
- Arizona Arrhythmia Research Center
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Arkansas
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Jonesboro、Arkansas、美国、72401
- Cardiology Associates of Northeast Arkansas
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California
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La Jolla、California、美国、92037
- Scripps Health
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Newport Beach、California、美国、92663
- Premier Cardiology, Inc.
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Stanford、California、美国、94305
- Stanford University Hospital
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Florida
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Ocala、Florida、美国、34471
- Munroe Regional Medical Center
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Tallahassee、Florida、美国、32308
- Tallahassee Research Institute
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital
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Gainesville、Georgia、美国、30501
- North Georgia Heart Foundation
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Iowa
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West Des Moines、Iowa、美国、50266
- Iowa Heart Center
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Kentucky
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Lexington、Kentucky、美国、40503
- Central Baptist Hospital
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Owensboro、Kentucky、美国、42304
- One Health Cardiology
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Michigan
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Lansing、Michigan、美国、48912
- Thoracic Cardiovascular Healthcare Foundation
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Missouri
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Columbia、Missouri、美国、65201
- Missouri Heart Center
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New Hampshire
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Manchester、New Hampshire、美国、03102
- Catholic Medical Center
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New Jersey
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Haddon Heights、New Jersey、美国、08035
- Cardiovascular Associates of Delaware Valley
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North Carolina
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Winston-Salem、North Carolina、美国、27103
- Forsyth Medical Center
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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals of Cleveland
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Oklahoma
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Tulsa、Oklahoma、美国、74104
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Lancaster、Pennsylvania、美国、17602
- Lancaster General Hospital
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Sayre、Pennsylvania、美国、18840
- Donald Guthrie Foundation for Education & Research
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South Carolina
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Greenville、South Carolina、美国、29605
- Greenville Health System
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Tennessee
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Chattanooga、Tennessee、美国、37403
- Erlanger Medical Center
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Germantown、Tennessee、美国、38138
- The Stern Cardiovascular Foundation
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Texas
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Plano、Texas、美国、75093
- The Heart Hospital Baylor Plano
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Washington
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Seattle、Washington、美国、98122
- Swedish Medical Center - Heart & Vascular
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Wisconsin
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Madison、Wisconsin、美国、53715
- St. Mary's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
" to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
- Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
- Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
- Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
- Are pregnant or planning pregnancy in the next 6 months
- Have a life expectancy of less than 24 months due to any condition
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 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：Treatment
Subjects implanted with the Quartet 1457Q LV lead
|
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 |
|---|---|---|
|
Number of Patients Free From LV Lead-related Complications Through 3 Months
大体时间：3 months
|
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead.
A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
|
3 months
|
合作者和调查者
调查人员
- 学习椅：David Delurgio, MD、Emory University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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