NL-OMON45274撤回不适用
AV-Node Stimulation to influence heart failure markers in Acutely Decompensated Heart Failure patients - AVNS-ADHF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
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 64（—）
入选标准
- •Inclusion criteria of training phase;Patients are eligible to be enrolled for the lead placement training procedure if one of the following criteria is met:
- •1) Indication for CRT implant according to current guidelines (Heart Failure, NYHA III-IV class, symptomatic despite optimal stable medical therapy, left ventricular (LV) ejection fraction <=35% and QRS>120ms);
- •2) Indication for ICD implant according to current guidelines;
- •3) Indication for pacemaker implant according to current guidelines.;Inclusion criteria of AVNS phase;1) Acutely decompensated HF as indicated by one of the symptoms such as
- •- shortness of breath (dyspnea)
- •- oedema (verified by chest X-ray) accompanied by severe respiratory distress, with crackles over the lungs and orthopnea, with Oxygen (O2) saturation usually < 90% on room air prior to treatment;
- •2) NYHA class III or IV at enrollment;
- •3) Age > 18 years;
- •4) Subject provides informed consent;
- •5) Subject is willing and able to comply with the study procedures;
- •6) Hospitalization for acute decompensated HF did start within the last 24 hours.
排除标准
- •Exclusion criteria for training phase;1) Advanced AV block (II-III degree AV block);
- •2) Potential damage to cardiac nerves involved due to one of the following
- •- ablation;
- •- valvular surgery;
- •- cardiac transplantation;
- •- aortic surgery;
- •3) Age < 18 years;
- •4) Patient not disposed to sign the Informed Consent;
- •5) Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] or sterile woman can be enrolled.
- •6) Subject is a breastfeeding woman;
- •7) Participation in other studies which could potentially conflict with this study;
- •8) Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.;Exclusion criteria for AVNS phase;1) Patients in cardiogenic shock. Cardiogenic shock is usually characterized by reduced blood pressure (BP) (< 90 mmHg) or a drop of mean arterial pressure > 30 mmHg and/or low urine output < 0.05 ml/kg/h with a pulse rate > 60 beats per minute (bpm) with or without evidence of organ congestion;
- •2) Heart rate below 50 bpm during sleep at night time and 60 bpm at day time;
- •3) Patient already implanted with a pacemaker or implantable cardioverter defibrillator;
- •4) Patient already implanted with a neurostimulation device;
- •5) Myocardial infarction, as defined by clinical symptoms and an increased cardiac Troponin T or I with a significant dynamic increment in 2 subsequent measurements [1], which occurred in the last 30 days, causing heart failure (an increased value for cardiac troponin is defined as a measurement exceeding the 99th percentile of a normal reference population [URL = upper reference limit]);
- •6) Heart failure due to congenital disease;
- •7) Hypertrophic obstructive cardiomyopathy;
- •8) Infiltrative cardiomyopathy;
- •9) Vasovagal syncope;
- •10) Advanced AV block (II-III degree AV block);
- •11) Congenital or acquired long QT syndrome;
- •12) Potential damage to cardiac nerves involved due to one of the following
- •- ablation;
- •- valvular surgery;
- •- cardiac transplantation;
- •- aortic surgery;
- •13) Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] or sterile woman can be enrolled.
- •14) Subject is a breastfeeding woman;
- •15) Participation in other studies which could potentially conflict with this study;
- •16) Diabetes mellitus with measured hemoglobin A1c > 8% in the past 60 days;
- •17) Untreated hypo- or hyperthyroidism;
- •18) Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
研究者
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