适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- CVRx Inc
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Age at least 21 years ;2.Bilateral carotid bifurcations that are easily interrogated by carotid duplex ultrasound and are below the level of the mandible. ;3.No ulcerative carotid arterial plaques or carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal or the distal common carotid, as determined within 45 days prior to randomization. ;4.Left ventricular ejection fraction <= 35% within 45 days prior to randomization. ;5.NYHA Class III within 45 days prior to randomization. ;6.Have a six-minute hall walk test performance: 150m <= 6MW <= 450m within 45 days prior to randomization. ;7.On optimal, stable pharmacological therapy for at least 4 weeks prior to obtaining the baseline echocardiographic measurement, where optimal and stable are defined as follows:
- •Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE inhibitor or ARB unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling. ;Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications. ;8.Not currently being treated with dialysis. ;9.Heart rate is between 60 and 110 b/min via a clinic measurement. ;10. If female and of childbearing potential, must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the study. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization. ;11. An appropriate surgical candidate. ;12. Signed a CVRx-approved informed consent form for participation in this study.
排除标准
- •1. Known or suspected baroreflex failure or autonomic neuropathy.
- •2. Body mass index of greater than 40.
- •3. Significant uncontrolled symptomatic bradyarrhythmias.
- •4. If the subject has recently received a pacemaker or an ICD implant, the subject may not be implanted until at least 90 days after the implant procedure. Patients with a CRT(D) implant may not be randomized untill 6 months after the activation of CRT therapy.
- •5. Solid organ or hematologic transplant.
- •6. Episode of NYHA class IV heart failure with acute pulmonary edema within 30 days prior to implant.
- •7. Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the 3 months prior to implant.
- •8. Prior surgery, radiation, or endovascular stent placement in the carotid sinus region, limiting the ability to place the carotid sinus lead.
- •9. Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
- •10. Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.
- •11. Primary cardiomyopathy or infiltrative heart disease.
- •12. Asthma, severe COPD (e.g. FEV1<1.5 liter), or severe restrictive lung disease.
- •13. Non-cardiovascular condition limiting the ability to assess the six-minute hall walk test.
- •14. Co-morbid medical condition that would adversely affect participation in the study.
- •15. Life expectancy less than one year.
- •16. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
- •17. Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements.
- •18. Enrolled in another concurrent clinical trial, without prior approval of CVRx.
- •19. Known allergy to silicone or titanium.
研究者
相似试验
终止
2 期
QUantum Genomics Incremental Dosing in Heart Failure - QUID-HFHeart FailureNCT02780180Quantum Genomics SA23
已完成
不适用
eural Cardiac Therapy for Heart Failure Studycardiac remodeling10019280Heart failureNL-OMON46859Boston Scientific20
招募中
不适用
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure PatientsHeart FailureLeft Bundle-Branch BlockNon-ischemic Dilated CardiomyopathyLeft Ventricular DysfunctionLeft Ventricular DyssynchronyLeft Ventricle RemodelingIschemic CardiomyopathyNCT05769036Tomsk National Research Medical Center of the Russian Academy of Sciences60
招募中
不适用
Retrospective analysis of heart failure patientsheart failureJPRN-UMIN000023840niversity of Fukui Hospital Department of Cardiovascular Medicine4,000
招募中
不适用
Prospective cohort study of patients with heart failure and/or heart failure wannabeesHeart failure, Cardiovascular disease, Coronary artery disease, Cardiomyopathy, Arrhythmia, Pulmonary hypertension, Sleep apnea syndrome, Hypertension, Diabetes, DyslipidemiaJPRN-UMIN000029132Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan10,000