BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 316
- 试验地点
- 183
- 主要终点
- Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
研究概览
简要总结
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
详细描述
The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter
- •On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
- •Office SBP ≥135 mmHg and <180 mmHg
- •Average 24-Hour aSBP ≥130 mmHg and <170 mmHg
排除标准
- •NYHA Class III-IV
- •History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
- •Myocardial infarction (MI) within 3 months
- •Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
- •Permanent atrial fibrillation
- •Mitral valve regurgitation greater than or equal to grade 3
- •Aortic stenosis with a valve area less than 1.5 cm2
- •Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
- •Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant
研究组 & 干预措施
Treatment Group
AVIM therapy activated with continued stable antihypertensive drug therapy
干预措施: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated (Device)
Control Group
AVIM therapy deactivated with continued stable antihypertensive drug therapy
干预措施: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated (Device)
结局指标
主要结局
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
时间窗: Baseline and 3 months post randomization
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
时间窗: 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
次要结局
未报告次要终点