Optimization of Cardiac Pacing Using CardioMEMS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pulmonary artery pressure changes
研究概览
简要总结
This study is designed to determine if a simplified technique for cardiac device reprogramming using pulmonary artery pressure (PAP) data in the acute setting holds promise to improve subjective assessments of patient quality of life (QOL), objective measurements of functional capacity, and specific systolic and diastolic echocardiographic indices.
详细描述
The present study is designed to determine if a simplified technique for cardiac device( CRT) reprogramming using pulmonary artery pressure (PAP) via implanted CardioMEMS device data in the acute setting holds promise to improve subjective assessments of patient quality of life (QOL), objective measurements of functional capacity, and specific systolic and diastolic echocardiographic indices. The protocol requires prospective collection and analysis of echocardiographic data, subjective symptoms (Minnesota Living with Heart Failure Questionnaires), and 6-minute walk distance measurements in patients with implanted biventricular pacemakers / defibrillators who are predominantly ventricularly paced, in normal sinus rhythm, have documented NYHA class 3 Heart Failure, and have implanted pulmonary artery pressure monitors (CardioMEMS, St. Jude Medical CRMD, St. Paul, MN). Data collection will occur at presentation (rest and with ambulation), one month post-reprogramming, and two months after evaluation and / or reprogramming.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have implanted PPM, ICD, or CRT devices and CardioMEMS
- •Patients can ambulate for 6 minutes and lay on a flat surface
- •Patients are paced > 95% of the time
- •Patients are not in acute CHF and are on a stable medication regimen
- •Patients have adequate echocardiographic windows
- •Patients can consent independently
排除标准
- •Patients with poor echocardiographic acoustical resolution.
- •Patients with congenital heart disease.
- •Patients with mechanical aortic or mitral valve replacements.
- •Patients with significant mitral annular calcification.
- •Patients with irregular heart rates: atrial fibrillation, supraventricular tachycardia, atrial premature contractions, and ventricular arrhythmia that would preclude data acquisition.
- •Patients unable to remain still secondary to movement disorders or agitation.
- •Inpatient status
- •Patients with poorly controlled HTN (SBP>160/90
结局指标
主要结局
Pulmonary artery pressure changes
时间窗: 30 days
Primary endpoint is changes in of pulmonary artery pressures within 30 days in patients who have optimization of pacing devices.
次要结局
未报告次要终点
研究者
Rita Jermyn, MD
Director of Center for Cardiac Therapeutics
St. Francis Hospital, New York