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临床试验/NCT03768804
NCT03768804Unknown不适用

Assessing the Effect of the SyncAV Algorithm in Cardiac Resynchronization Therapy on Exercise Capacity and QRS Duration on Exercise

University of Oxford2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
试验地点
2
主要终点
Exercise capacity

研究概览

简要总结

In patients with weak pumping function of the heart, uncoordinated contraction of the chambers can be corrected using a cardiac resynchronization therapy ("CRT") pacemaker. These devices make patients live longer by improving how the heart pumps and reducing symptoms such as breathlessness. However, not all patients benefit from CRT and programming devices optimally can greatly influence success. Predicting the correct timings of contraction between the atria (top chambers of the heart) and the ventricles (bottom chambers), as well as between the left and right ventricles, especially when heart rate increases during exercises, is challenging.

A new approach to optimizing CRT programming has been proposed known as 'fusion-pacing'. This allows the electrical wave from the heart's own conduction system to merge or fuse with the impulse from the pacemaker in the left ventricle. The timing of the pacemaker's impulse is continuously adjusted to measurements the device makes of the hearts natural conduction. What is not clear is how effective 'fusion-pacing' is during exercise when the hearts natural conduction changes rapidly and unpredictably. We plan to investigate this by monitoring the electrocardiogram ("ECG") whilst accurately measuring exercise performance and ability during a cardiopulmonary exercise test ("CPET") on an exercise bike. We will also ask participants to rate their perceived exercise intensity to see whether fusion pacing improves ECG resynchronization, exercise performance, and patients' symptoms compared to standard programming.

详细描述

Heart failure represents a significant health problem, with the last national heart failure audit demonstrating prevalence in the United Kingdom of 900,000 patients, accounting for 5% of all acute hospital admissions. This is expected to increase with an ageing population. Despite improvements in medical therapy, prognosis remains poor, with an in- hospital mortality of 9.6%, and an estimated mortality of 30-40% at 1 year after diagnosis.

Multiple randomised controlled trials have demonstrated that cardiac resynchronization therapy pacemaker devices ("CRT") are an effective therapy for patients with poor pumping function and altered electrical conduction of the heart (left bundle branch block, "LBBB"), improving both morbidity and mortality. However, only 60-70% of patients notice a symptomatic improvement with CRT and even in patients who do respond, response can often be improved further by optimising how the device is programmed.

CRT devices improve coordination of heart pumping by pacing both ventricles of the heart. A key function of this is to coordinate the timing of contraction of the the atria and the ventricles (atrio-ventricular, or "AV", optimisation). This allows maximal filling of the left ventricle with blood. More recently, it has become important not only in standard bi-ventricular ("BiV") pacing, but to allow left ventricular pacing to be timed with intrinsic conduction to the right ventricle to provide CRT (so called 'fusion' pacing).

Multiple methods have been described to assess AV optimisation, including echocardiographic measurements. However, echo based methods are labour intensive, and their value is uncertain. Device algorithms utilising analysis of the intra-cardiac electrogram ("IEGM") have become an attractive alternative due to their rapid and automated nature, although evidence suggests that they may not have clinical benefit over using fixed AV delays. In addition, intrinsic AV conduction is known to alter with exercise, normally becoming shorter. Optimisation of AV delays in CRT on exercise has been shown to improve cardiac output. Device algorithms can therefore allow dynamic adjustment of AV delays as they change with exercise and heart rate (rate-adaptive AV delay or "RAAVD"). Indeed, use of individually tailored RAAVD in CRT patients has demonstrated an increase in exercise capacity.

Patients with heart failure and LBBB often have normal intrinsic right ventricular activation through the right bundle. Utilization of timed left ventricular ("LV") pacing to merge (or fuse) with this intrinsic conduction may confer benefits over standard BiV pacing, but requires relatively normal intrinsic AV conduction as well as correct timing of LV pacing to right ventricular ("RV") activation. Algorithms now exist which allow dynamic reassessment of intrinsic conduction and so adjustment of the optimal AV delay. They can therefore compensate for changes in the intrinsic AV delay on exercising, and so maintain adequate fusion pacing and CRT optimisation. One such software algorithm is SyncAV, developed by Abbott (Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054-2807). SyncAVTM assesses intrinsic AV conduction every 256 beats. It then sets a shorter programmed AV delay by subtracting a set period (known as the "delta" - adjustable but nominally set to 50ms) from the intrinsic time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Age ≥18 and able to give informed consent.
  • Patients with existing cardiac resynchronization therapy ("CRT") devices able to utilise the SyncAV algorithm, implanted ≥6 months and under follow up at Oxford University Hospitals National Health Service ("NHS") Foundation Trust.
  • Evidence of response to CRT, defined as functional improvement or left ventricular ("LV") remodelling on imaging.
  • Sinus rhythm and PR interval <250ms.
  • Able to exercise to perform cardiopulmonary exercise testing ("CPET").

排除标准

  • Pregnancy or breast feeding.
  • Atrial fibrillation or atrial tachycardia.
  • Underlying 2nd or 3rd degree heart block.
  • PR interval ≥250ms.
  • Chronotropic incompetence, defined as use of rate-response algorithm or ≥80% atrial pacing.
  • Any concurrent condition contraindicating use of CPET.

结局指标

主要结局

Exercise capacity

时间窗: 1 Year

Exercise capacity as measured by cardiopulmonary exercise testing ("CPET") including blood sampling

BORG-RPE rating

时间窗: 1 Year

Borg rating of perceived exertion ("Borg-RPE") during CPET

次要结局

  • PR duration(1 Year)
  • Exercise duration(1 Year)
  • QRS duration(1 Year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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