NCT00158977已完成3 期
CONTAK RENEWAL 3 AVT Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
研究概览
简要总结
The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of or at risk of developing atrial and ventricular arrhythmias
详细描述
A clinical evaluation to:
- Confirm that there are no adverse interactions when Ventricular Tachyarrhythmia (ICD), Heart Failure (HF) and Atrial Tachyarrhythmia (AT) therapies are combined
- Confirm Cardiac Resynchronization Therapy (CRT) and Ventricular Tachyarrhythmia (ICD) therapy is delivered in the presence of atrial therapies
- Demonstrate the safety and effectiveness of atrial therapies in a heart failure population
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 who meet the following criteria should be given consideration for inclusion in the clinical investigation:
- •Meet all device indications and contraindications
- •Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
- •Prescribed to stable optimal pharmacologic therapy for heart failure
- •Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Geographically stable residents who are available for follow-up
- •Able to provide documented evidence of one or more episodes of AF/AT within 12 months of implantation
- •NOTE: Guidant recommends anticoagulation therapy per physician discretion.
排除标准
- •Patients who will be excluded from the investigation are those who meet any one of the following criteria:
- •Have a preexisting non-Guidant left ventricular lead
- •Have a preexisting unipolar pacemaker that will not be explanted/abandoned
- •Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- •Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
- •Have a known hypersensitivity to a 0.7 mg dose of dexamethasone acetate
- •Have surgically uncorrected primary valvular heart disease
- •Currently requiring hemo-dialysis
- •Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
- •Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- •Have a mechanical tricuspid heart valve
- •Enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
- •A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
- •During the four weeks prior to implantation, a patient experiences an episode of AF ³ 48 hours in duration and was not anticoagulated at an adequate therapeutic level for the 4 weeks prior to enrollment with an INR = 2.0-3.0 at enrollment
- •Women who are pregnant or plan to become pregnant
- •Note: Women of childbearing potential must have a negative pregnancy test within 7 days of enrollment
结局指标
主要结局
Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
时间窗: 3 months
Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
时间窗: 3 months
Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms
时间窗: 3 months
次要结局
- Safety Endpoint: Ventricular Fibrillation (VF) Detection Time(3 months)
- Safety Endpoint: Percent BiV Pacing(3 months)
- Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate(3 months)
- Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature(3 months)
研究者
研究点 (1)
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