Clinical Evaluation of Safety and Performance of the BackBeat Moderato System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 17
- 主要终点
- Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
研究概览
简要总结
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subject is ≥ 18 years of age
- •Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
- •Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
- •Subject has office systolic blood pressure measurements > 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg
排除标准
- •Subject has known secondary cause of HTN
- •Subject has a history of atrial fibrillation
- •Subject has ejection fraction <50%
- •Subject has symptoms of heart failure of NYHA Class II or more
- •Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- •Subject is on dialysis
- •Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
- •Subject has prior neurological events (stroke or TIA) or carotid artery disease
- •Subject has known autonomic dysfunction
- •Subject has a history of clinically significant tachyarrhythmia
- •Subject has had previous active device-based treatment for hypertension
- •Subject has an existing implant, other than a pacemaker that needs replacing
- •Subject with average Systolic BP >190 mmHg
研究组 & 干预措施
Treatment
This is an unblinded, treatment only study in which each patient serves as his or her own control.
All patients who meet entry criteria will undergo implantation of the Moderato System. During the first month the pacemaker Performance will be evaluated and an additional 3 month period of treatment for studying the Moderato-HTN therapy effect.
干预措施: The Moderato System (Device)
结局指标
主要结局
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
时间窗: 4 months
Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment
时间窗: 3 months
Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure.
时间窗: 3 months
Moderato - Hypertension device performance will be evaluated through analysis of 24 hour Holter monitoring recordings. The device will be considered to be efficacious if there is a reduction of average office blood pressure and/or a reduction in averaged mean 24-hour ambulatory blood pressure.
Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events.
时间窗: 4 months
The pacemaker function of the system will be considered to be safe if the rate and severity of pacemaker-related complications is not greater than reported in the literature for similar devices.
次要结局
未报告次要终点