NL-OMON46859已完成不适用
eural Cardiac Therapy for Heart Failure Study - NECTAR-HF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age 18 or above, or of legal age to give informed consent specific to national laws
- •* Willing and capable of providing informed consent
- •* Capable of participating in all testing associated with this clinical investigation
- •* Symptomatic heart failure NYHA class II or III
- •* Left ventricular (LV) ejection fraction <= 35% documented in patient file within the past 6 months
- •* Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater documented in patient file within the past 6 months
- •* Prescribed to optimal pharmacologic therapy according to current local or international guidelines for treatment of acute and chronic heart failure at the time of enrollment, unless contra-indicated or not-tolerated, and on a stable dose (e.g., recommended no greater than a 100% increase or 50% decrease in dosage) for at least 30 days prior to enrollment
排除标准
- •* Patients with Cardiac Resynchronization Therapy for less than one year prior to enrollment
- •* Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
- •* Patients unable to tolerate anesthesia required for implant
- •* Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrollment
- •* Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
- •* Patients with persistent or permanent atrial fibrillation (AF) (according to the current local or international guidelines for the management of patients with AF at the time of enrollment) within 90 days prior to enrollment
- •* Pacemaker indicated patients
- •* Patients whose heart failure is due to congenital heart disease
- •* Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP, APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment
- •* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- •* Patients with documented chronic obstructive lung disease, defined as forced expiratory volume at 1 sec/forced vital capacity < 60%
- •* Patients on or indicated for renal dialysis
- •* Type 1 diabetic patients
- •* Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment
- •* Patients with a life expectancy of less than 12 months per physician judgment
- •* Patients involved in any concurrent clinical investigation (observational/governmental registries are allowed)
- •* Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician*s discretion) or breastfeeding
- •* Patients with a prior cardiac transplant or expecting an heart transplant operation within the next 12 months
- •* Patients with a prior vagotomy
- •* Patients with prior or existing vagal nerve stimulation treatment
- •* Patients implanted with any active implantable medical device other than:
- •o A left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or
- •o A left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30.
- •* Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system
- •* Patients with previously implanted devices on the right side that became infected before removal
- •* Patients with previous neck or upper chest surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc)
- •* Patients with known recurrent nerve paralysis
- •* Patients who have undergone radiotherapy for thyroid disease/cancer
- •* Patients who have existing or prior tracheostomy
- •* Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
- •* Patients with carotid murmur/vascular bruit/ca
研究者
相似试验
尚未招募
不适用
Clinical study on intervention of heart failure patients after myocardial infarction with Wuqinxi based on the theory of ''supporting yang''Postinfarction heart failureITMCTR2022000105Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine
已完成
不适用
Pilot study for the treatment of heart failure with PycnogenolCirculatory SystemHeart failureISRCTN22412590Kyoto University (Japan)30
已完成
不适用
Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zincheart failureJPRN-UMIN000020203Tokorozawa Heart Center, Medical Corporation Ouyuukai50
撤回
不适用
eo Randomized Heart Failure Studyheartfailuredecompensatio cordis10019280NL-OMON38346CVRx Inc20
尚未招募
4 期
ovel Interventions in Heart Failure with Preserved Ejection Fraction using TadalafilHeart Failure with Preserved Ejection FractionCardiovascular - Other cardiovascular diseasesACTRN12612000684820South Australian Health and Medical Reseasrch Institute20