Continued Access Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the Paradym RF SonR CRT-D
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Report HF-related events
研究概览
简要总结
The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient population that is reflective of current heart failure treatment practice.
详细描述
Since the introduction of cardiac resynchronization therapy (CRT) on a large scale, it has been observed that approximately 30% of recipient patients are non-responsive to therapy. This non-responsiveness can be decreased by optimizing the device programming, particularly the stimulation rate, paced and sensed atrioventricular (AV) delay, and the interventricular (VV) delay.
All CRT patients need a 100% rate of ventricular capture, but beyond this the achievement of therapy effectiveness requires the identification of the optimal pacing configuration, which varies among patients. The optimization of CRT systems, usually based on ultrasound imaging is time-consuming and the number of patients in need of multiple optimization procedures due to ventricular remodeling is growing rapidly.
The mechanical effects of a more coordinated contraction result in a shortening of the isovolumetric contraction phase and the pre-ejection time, and an increase in LV dP/dt (change in left ventricular pressure over time. The concept of measuring contractility with an implantable accelerometer was first clinically validated through a multicenter study on a rate responsive pacing system (BEST - Living from SORIN Biomedica) in 1996. This study positively demonstrates that measurement of Peak Endocardial Acceleration signal (called PEA or SonR) is feasible and reliable in the long-term, both for the purpose of rate response and as a hemodynamic monitor of cardiac function.
More recent clinical studies have demonstrated that optimal VV and AV Delays determined using algorithms based on SonR signal analysis (SonR method) are correlated with the highest hemodynamic improvement and lead to significant clinical benefit for the patients, thus reducing the rate of non-responsiveness to CRT therapy.
Therefore, frequent and automatic AV and VV delay optimization in patients with CRT-D devices could benefit both patients, through increasing the percent of CRT responders, and clinicians, through simplifying CRT optimization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients who meet all the following criteria at the time of enrollment may be included:
- •Patient with a class I and IIa indication for implantation of a CRT-D device according to current available guidelines
- •Moderate/Severe HF (NYHA Class III or ambulatory IV)
- •LVEF ≤ 35 %
- •LBBB: QRS ≥ 120 ms ; non-LBBB : QRS ≥ 150 ms
- •On a stable optimal drug regimen
- •Patient is in sinus rhythm at the time of signing the informed consent
- •Signed and dated informed consent
排除标准
- •Patients who meet any one of these criteria will be excluded from the investigation:
- •Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrollment
- •Incessant ventricular tachyarrhythmia
- •Unstable angina, or MI, CABG, or PTCA within the past 4 weeks
- •Correctable valvular disease that is the primary cause of heart failure
- •Recent CVA or TIA (within the previous 3 months)
- •Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month**
- •Post heart transplant (patients who are waiting for a heart transplant are allowed in the study)
- •Renal failure (GFR<15 ml/min/1.73m2) or on dialysis
- •Previous implant with a CRT- P or CRT-D device
- •Concurrent implant with another pacemaker or ICD system in which all or some of the components will not be extracted and/or utilized in the new system. Previously implanted RA leads must be removed prior to implant of the SonRtip lead.
- •Already included in another clinical study that could confound the results of this study
- •Life expectancy less than 1 year
- •Inability to understand the purpose of the study or to understand and complete the QOL questionnaire
- •Unavailability for scheduled follow-up or refusal to cooperate
- •Sensitivity to 1 mg Dexamethasone sodium phosphate (DSP)
- •Age of less than 18 years
- •Substance addiction or abuse
- •Under guardianship
研究组 & 干预措施
Treatment
This is a single-arm trial. All patients will be implanted with the PARADYM RF SONR CRT-D device and the SonRtip bipolar atrial lead. After successful implant, all patients will be programmed with the SonR automatic optimization feature turned ON ("AV+VV").
干预措施: SonR automatic optimization feature turned ON ("AV+VV"). (Device)
结局指标
主要结局
Report HF-related events
时间窗: 12 months
All patients implanted with the entire system
Report Quality of Life improvement
时间窗: 12 months
All patients implanted with the entire system
SonRtip Lead, pacing threshold
时间窗: 12 months
All patients implanted with the SonRtip lead
SonRtip Lead, sensing amplitude
时间窗: 12 months
All patients implanted with the SonRtip lead
Acute SonRtip Lead Complication-Free Rate
时间窗: Month 3
All patients implanted with the SonRtip lead
Chronic SonRtip Lead Complication-Free Rate
时间窗: From month 3 to month 12
All patients implanted with the SonRtip lead
Report NYHA class improvement
时间窗: 12 months
All patients implanted with the entire system
SonRtip Lead, pacing impedance
时间窗: 12 months
All patients implanted with the SonRtip lead
Report deaths from any cause
时间窗: 12 months
All patients enrolled
Report echocardiographic parameters trend
时间窗: Month 12
All patients implanted with the entire system
Report Adverse Events
时间窗: 12 months
All patients enrolled
次要结局
未报告次要终点