Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events
研究概览
简要总结
The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. Measurements of right ventricular, left ventricular function, and exercise capacity will be obtained at various LBBAP programming parameters at rest and during low intensity exercise. The main aims of the study are:
- Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode.
- Generate preliminary data evaluating differences in RV function, LV function, and exercise capacity during various pacemaker programming settings.
详细描述
Conduction system pacing, namely left bundle branch area pacing (LBBAP) represents an important pacing modality introduced to avoid the deleterious effects of non-physiologic ventricular activation during chronic right ventricular pacing and /or left bundle branch block (LBBBP). Previous studies have demonstrated that LBBAP exhibits similar or superior left ventricular resynchronization compared to conventional treatment modalities, the impact of this novel pacing strategy on the right ventricle has not yet been addressed. This study aims to demonstrate the safety and feasibility of assessing LBBAP performance with a focus on right ventricular function in a novel way utilizing Cardiopulmonary Exercise Testing and Exercise Stress Cardiac Magnetic Resonance.
The investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise CPET-CMR at three different LBBAP settings (underlying rhythm, non-selective left bundle pacing, non-selective left bundle pacing with anodal stimulation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •presence of dual chamber LBBAP implantation
- •presence of anodal capture with bipolar pacing configuration as determined at pacing implant.
排除标准
- •Known history of chronotropic incompetence
- •high degree or complete heart block
- •inability to tolerate NVP during initial device interrogation
- •pregnancy
- •inability to undergo MRI or exercise utilizing supine bicycle at target work-load
- •presence of MRI unsafe pacemaker components.
研究组 & 干预措施
Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP)
Phase 3 (Left Bundle Branch Area Pacing with Anodal Capture or aLBBAP) will assess right and left ventricular function at rest and during exercise with left bundle branch area pacing with anodal capture.
干预措施: Pacemaker Interrogation and Electrocardiogram (ECG): (Other)
Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP)
Phase 3 (Left Bundle Branch Area Pacing with Anodal Capture or aLBBAP) will assess right and left ventricular function at rest and during exercise with left bundle branch area pacing with anodal capture.
干预措施: Continuous pacemaker telemetry (CPT) (Other)
No Ventricular Pacing (NVP)
Assessment 1 (No Ventricular Pacing) will be performed with no ventricular pacing to assess baseline right and left ventricular function at rest and during exercise.
干预措施: Pacemaker Interrogation and Electrocardiogram (ECG): (Other)
No Ventricular Pacing (NVP)
Assessment 1 (No Ventricular Pacing) will be performed with no ventricular pacing to assess baseline right and left ventricular function at rest and during exercise.
干预措施: Continuous pacemaker telemetry (CPT) (Other)
Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP)
Phase 2 (non-selective or selective Left Bundle Branch Area Pacing or ns/sLBBAP) will assess right and left ventricular function at rest and during exercise with non-selective or selective left bundle branch area pacing
干预措施: Pacemaker Interrogation and Electrocardiogram (ECG): (Other)
Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP)
Phase 3 (Left Bundle Branch Area Pacing with Anodal Capture or aLBBAP) will assess right and left ventricular function at rest and during exercise with left bundle branch area pacing with anodal capture.
干预措施: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR (Other)
No Ventricular Pacing (NVP)
Assessment 1 (No Ventricular Pacing) will be performed with no ventricular pacing to assess baseline right and left ventricular function at rest and during exercise.
干预措施: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR (Other)
Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP)
Phase 2 (non-selective or selective Left Bundle Branch Area Pacing or ns/sLBBAP) will assess right and left ventricular function at rest and during exercise with non-selective or selective left bundle branch area pacing
干预措施: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR (Other)
Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP)
Phase 2 (non-selective or selective Left Bundle Branch Area Pacing or ns/sLBBAP) will assess right and left ventricular function at rest and during exercise with non-selective or selective left bundle branch area pacing
干预措施: Continuous pacemaker telemetry (CPT) (Other)
结局指标
主要结局
Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events
时间窗: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Incidence of pacemaker atrial (P Wave) over sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.
次要结局
- Incidence of Pacemaker Atrial (P Wave) Under-Sensed Events(Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.)
- Left Ventricular Ejection Fraction (%)(Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.)
- Right Ventricular Ejection Fraction (%)(Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.)