Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 12
- 主要终点
- SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
研究概览
简要总结
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.
However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.
This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.
In this crossover trial, participants will be upgraded to a physiological pacing strategy.
After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).
They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.
Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.
The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.
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
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:
- •EF reduced by >5% of increase in LVESV by 10ml since implant
- •NT-proBNP >250ng/L in sinus rhythm
- •NT-proBNP > 750 Ng/L if AF
- •Left atrial volume index > 30ml/m2
- •Regular loop diuretics prescribed
- •Decline in daily patient activity by >1 hour per day since implant
- •Decrease in device measured thoracic impedance
- •Patient reported decline in functional class or exercise tolerance
排除标准
- •Those unable to provide informed consent
- •Patients under age 18
- •Pregnant women
研究组 & 干预措施
Physiological Pacing (Conduction System Pacing or Biventricular Pacing)
The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
干预措施: Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) (Device)
Right Ventricular Pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)
干预措施: Continued RV Pacing (Right Ventricular Pacing) (Device)
结局指标
主要结局
SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
时间窗: From date of baseline, until end of trial follow-up at fourteen months post-baseline
次要结局
- Minnesota Living with Heart Failure Questionnaire(From date of baseline, until end of trial follow-up at fourteen months)
- Six-minute walk test(From date of baseline, until end of trial follow-up at fourteen months)
- Atrial fibrillation(From date of baseline, until end of trial follow-up at fourteen months)
- Left ventricular ejection fraction(From date of baseline, until end of trial follow-up at fourteen months)
- Left ventricular end systolic volume(From date of baseline, until end of trial follow-up at fourteen months)
- Safety endpoints(From device implant date, assessed up to 15 months at the end of the trial (including a one-month run-in period post-procedure prior to the first baseline visit))
- SF-36 (Short Form 36 Health Survey Questionnaire) Overall Score(From date of baseline, until end of trial follow-up at fourteen months post baseline visit)
- Patient preference based on blinded symptomatic preference(At 2 months following baseline and 14 months following baseline visit)
- EQ-5D Questionnaire(From date of baseline, until end of trial follow-up at fourteen months post-baseline visit)
- Patient symptoms assessed on a scale of 0-100 monthly(From date of baseline, until end of trial follow-up at fourteen months post-baseline visit)
- SF-36 (Short Form 36 Health Survey Questionnaire) Individual Component Scores(From date of baseline, until end of trial follow-up at fourteen months post baseline visit)
- BNP (B-type natriuretic peptide)(From date of baseline, until end of trial follow-up at fourteen months post baseline visit)