NCT03210402已完成不适用
REmodeling the Left Ventricle With Atrial Modulated Pacing
Medtronic Cardiac Rhythm and Heart Failure20 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 20
- 主要终点
- Number of Participants Who Remained on Study
研究概览
简要总结
New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 3 months
- •Subject is stable on current medications
- •Subject has dyspnea with exertion or diagnosed as New York Heart Association (NYHA) Class II or III Heart Failure
- •Subject has had a prior Echo in past 6 months with: Ejection Fraction (EF) ≥ 50% and Diastolic volume <80 ml/m²
- •Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m², women 95 g/m² or indexed to height: men 49.2 g/m2.7, women 46.7 g/m2.7) or Relative Wall thickness >0.42, or Wall Thickness>1.2cm (posterior wall)
- •Subject is willing to sign and date the study Informed Consent Form (IC Form) - Subject is 18 years of age or older, or of legal age to give informed consent per local law
- •Subject is expected to remain available for follow-up visits
排除标准
- •Subject has permanent atrial fibrillation (AF) or AF noted on baseline interrogation rhythm strip
- •Subject has uncontrolled BP; (systolic pressure needs to be >100 mmHg and <160 mmHg on medications)
- •Subject has severe stenosis of the aortic or mitral valve, defined as valve area ≤1.0 cm² or severe regurgitation of the aortic or mitral valve
- •Subject has symptomatic Chronic Obstructive Pulmonary Disease (COPD) requiring oxygen
- •Subject's Pacemaker has less than 6 months of Pacemaker battery life
- •Subject had an aortic valve replacement (surgical or TAVR) procedure less than 9 months prior to enrollment
- •Subject's programmed upper rate limit is less than 100 bpm because of concerns of elevated pacing
- •Subject is unable or unwilling to perform the 6 Minute Walk Test at all scheduled study visits
- •Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager)
- •Subject is pregnant
- •Subject meets any exclusion criteria required by local law
- •Subject's life expectancy is less than 12 weeks
- •Subject with medical condition that precludes the patient from participation in the opinion of the investigator
- •Subject has known coronary disease with Class II angina
结局指标
主要结局
Number of Participants Who Remained on Study
时间窗: Baseline through 12 week follow-up
REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.
次要结局
未报告次要终点
研究者
研究点 (20)
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