Pressure-Volume (PV) Measurements for Evaluating Cardiac Parameters Using BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals in Different Physiological Pacing Sites: An Acute Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Average changes in Systolic Blood Pressure Change
研究概览
简要总结
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG.
Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure
详细描述
This will be a multi-center, pilot, open-label, non-randomized acute study. The Moderato System is approved for marketing in Europe (has a CE mark) for standard pacing and the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato® System is referred to as CNT (Cardiac Neuromodulation Therapy).
This investigation will evaluate the effect of different pacing lead positions on cardiac function and the modulation of the autonomic nervous system using Cardiac Neuromodulation Therapy (CNT) pacing signals. The Study includes both patient who have hypertension and patients that do not have hypertension. Moderato®system is currently not indicated for patients that do not have hypertension.
Subjects indicated for an implant or replacement of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D) who meet the study inclusion and exclusion criteria may participate in the study and will undergo the following procedure during their device implantation or replacement:
A Right Atrial (RA) lead will be positioned according to standard procedure of the initially planned device implant, or kept in place (in device replacement), or only temporarily introduced and used for the trial procedure. Existing ventricular leads (if any) can be used for the trial procedure, too. The ventricular lead will be temporarily positioned in the different pacing sites according to the following order: RV septal, LBBA, LBB. Pacing and CNT will be performed in each of these sites unless the site is unreachable or pacing is not possible. When trial procedures are finished, the ventricular lead will be positioned according to best practices of the implant or replacement procedure the patient is undergoing. Any lead used temporarily would be removed.
The leads will be connected to a BackBeat Moderato® System IPG, externally to the patient, using a single use, sterile Pacing System Analyzer (PSA) cable provided by the hospital. The Moderato®IPG - which is approved for chronic CNT delivery in hypertensive patients - will function in this trial as a temporary external CNT signal generator for acute application of the therapy; it will not be in direct contact with the subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 an implant or a replacement with a planned upgrade of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D).
- •Subject is willing and able to comply with the study procedures.
排除标准
- •Subject is dependent on 100% ventricular pacing.
- •Subject has symptoms of heart failure, NYHA Class III or greater
- •Subject has an ejection fraction of 25% or less
- •Subject's systolic blood pressure is less than 100 mmHg on the day of implant
- •Subject has decompensated heart failure
- •Subject has significant (>2+) valvular regurgitation or any valvular stenosis.
- •Subject has permanent atrial fibrillation
- •Subject has atrial fibrillation on the day of the study.
- •Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm
- •Subject is on dialysis
- •Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit.
- •Subject has a history of autonomic dysfunction
- •Patient cannot receive heparin for any reason (such as a history of Heparin induced thrombocytopenia (HIT))
- •Women who are pregnant or breast-feeding
- •Subject cannot or is unwilling to provide informed consent.
研究组 & 干预措施
Experimental group
Eligible subjects instrumented for CNT testing
干预措施: Moderato (Device)
结局指标
主要结局
Average changes in Systolic Blood Pressure Change
时间窗: through study completion (18 months)
When compared to standard pacing, CNT elicits a reduction in Systolic Blood Pressure (mmHg)
次要结局
- Average Cardiac Volumes (End Diastolic and End Systolic volumes, stroke volumes)(through study completion (18 months))
- Average Ejection Fraction (the percent of blood volume ejected per beat)(through study completion (18 months))
- Average Cardiac Pressures (End Systolic and Diastolic Pressures)(through study completion (18 months))
- Average cardiac contractility(through study completion (18 months))
- Average Systemic Vascular Resistance(through study completion (18 months))