NL-OMON46157撤回不适用
Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension: A Double-Blind Randomized Trial - Moderato System: A Double-Blind Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
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) Subject is * 18 years of age
- •2) Subject requires the implant or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker
- •3) Subject has stable (for prior 6 weeks) hypertension treatment with at least 1 antihypertensive drug, which is anticipated to be able to be maintained without changes .Stable is defined as being on the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks
- •4) Subject has an average 24 hour ambulatory systolic blood pressure of * 130mmHg (with directly observed medical therapy, DOT) and unattended automatic average and office systolic blood pressure *140 mmHg
- •5) Subject is able to comply with study visits for at least 13 months (e.g., is capable
- •and is willing to travel to/from the center for all scheduled study visits)..
排除标准
- •1) Subject has a known secondary cause of HTN
- •2) Subject with average ambulatory or office systolic BP >195 mmHg
- •3) Subject has permanent atrial fibrillation
- •4) Subject has a history of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats). Fibrillation/flutter burden will be determined by pacemaker interrogation (for those already having a pre-existing pacemaker) or, otherwise, by patient history.
- •5) Subject has ejection fraction <50%
- •6) Subject has symptoms of heart failure, NYHA Class II or greater
- •7) Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness *15 mm
- •8) Subject is on dialysis
- •9) Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
- •10) Subject has prior neurological events (stroke or TIA) within the past year or an event at any prior time that has resulted in residual neurologic deficit
- •11) Subject has a history of significant carotid artery disease (>50% occlusion of left or
- •right carotid artery)
- •12) Subject has a history of autonomic dysfunction
- •13) Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced cardiac arrest
- •14) Subject has had previous active device-based treatment for hypertension
- •15) Subject has an existing implant, other than a pacemaker that needs replacing
- •16) Subject is pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study.
- •17) Subject cannot or is unwilling to provide informed consent.
研究者
相似试验
已完成
3 期
Evaluation of the Clinical Safety and Efficacy of Suprimun in Renal Transplant RecipientsComparative Interventional Treatment for reduceing the renal transplant rejection.kidney transplant rejectionIRCT2013012612274N1Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences100
已完成
3 期
Evaluation of the Clinical Safety and Efficacy of Suprimun in Renal Transplant RecipientsComparative Interventional Treatment for reduceing the renal transplant rejection.kidney transplant rejectionIRCT2014072118548N1Research Deputy of Kermanshah University Of Medical Sciences60
已完成
不适用
Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Harvest Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic UlcersISRCTN28965380Harvest Technologies Corp. (USA)59
已完成
不适用
The evaluation of the clinical effect and safety of stereotactic body radiationtherapy for hepatocellularcarcinomaJPRN-UMIN000016834Hiroshima university100
进行中（未招募）
Unknown
Safety and effectiveness clinical evaluation of injectable medical device Hydragel A1 in the skin quality improvementPatient seeking aesthetic treatment of the facial skin quality such as skin elasticity or firmness and facial skin radianceISRCTN10640292ouna Aesthetics40