Postmarketing, Prospective, Multicenter, Randomized and Blinded Study to Evaluate the Superior Efficacy of Cardiac Resynchronization Using the SyncAVTM Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 15
- 主要终点
- Number of responders patients evaluating the superiority of CRT with ventricular stimulation with fusion using the SyncAV TM algorithm versus BiV conventional stimulation
研究概览
简要总结
Heart Failure (HF) is a cardiovascular disease secondary to a structural and / or functional alteration of the heart that prevents its correct function.
The Cardiac resynchronization therapy (CRT) aims to restore atrioventricular, inter and intraventricular synchrony in patients with systolic HF and wide depolarization of the ventricles (QRS). Although CRT has been shown to be effective, the rate of non-responders is high (30-50%).
One of the proposed reasons for the lack of response to the CRT is the lack of intrinsic conduction, since most of the time CRT is administered using biventricular stimulation (BiV). One of the limitations to achieve ventricular fusion are the dynamic physiological variations of the auriculo-ventricular (AV) interval.
The SyncAVTM algorithm is a new dynamic algorithm that manages to adjust the AV intervals outside the clinic.
The design of the present clinical study is post-marketing, prospective, multicenter, randomized and blind for the patient and the central echocardiography laboratory.
The objective of this study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with conventional BiV stimulation in the population for which its use is foreseen.
The data will be collected in at least the Selection / Baseline Visit and in the Visit of Follow-up at 6 Months.
The study population are subjects to whom an Abbott Medical CRT has been implanted with SyncAVTM® Stimulation function that go to the participating sites in the study.
The main objective of the study is to assess whether CRT with ventricular stimulation with fusion using the SyncAVTM algorithm is superior to CRT with BiV stimulation conventional in terms of the rate of responders.
The main endpoint is the determination of significant differences between conventional BiV stimulation and ventricular stimulation with fusion using the SyncAVTM algorithm in terms of the percentage of patients responding to CRT therapy with echocardiogram.
The duration of the clinical study is estimated at 24 months with a recruitment period of 18 months and a patient follow-up of 6 months. The number of subjects that is planned to be recruited is 176. The inclusion will be competitive and there is no inclusion number determined per site.
详细描述
Study design The study is designed post-marketing, prospective, multicenter, randomized and blind for the patient and for the Core-laboratory of the echocardiogram (ECO) department. Has this design is post- marketing since it is a sanitary product with European Committee (CE) marking that is already commercialized and will be used in the study according to its instructions for use. Is a blind study since neither the participant subject nor the Core-laboratory of the ECO (person in charge to assess the main variable of the study) know the treatment that has been randomized the subject, it is a randomized study because the group assignment of each subject is done randomly 1:1.
Study evaluation Evaluation of the risk and benefits of the study: The following will be taking into account
- Expected clinical benefits:
- Stimulation function with the SyncAV algorithm is expected increase the rate of responders to therapy.
- These two methods improve function VI (ventricle left) and it is believed that this additional improvement of the VI function could benefit patients who do not respond to BiV conventional stimulation.
- Expected adverse effects of the product: bleeding/acute hemorrhage, gas aeration, acceleration of arrythmias, cysts formation, erosion,exacerbation of cardiac insufficiency, venous or cardiac perforation, excessive fibrous tissue development, bruising, histotoxic reactions, infection, keloid formation, myocardial irritability, infection, hematoma, excessive bleeding, local tissue reaction, loss of stimulation and/or detection due to migration or mechanical malfunction, myocardial irritability, stimulation of the nerve, etc. All those events are inherent to the implant of the device for cardiac resynchronization therapy
- Risk associated with participation in this clinical trial: It is expected that the risks associated with the use of the SyncAVTM stimulation algorithm be comparable to the risks associated with other types of ventricular pacing, and therefore, the risks associated with the use of the stimulation algorithm are expected SyncAVTM will not differ from the risks associated with the different modes of Conventional stimulation available. Patients will be included in the study after the successful implantation of a CRT device, whose indication will be made clinically based on the guidelines current clinical practice of the European Society of Cardiology (ESC).
- Possible interactions with concomitant medical treatments and / or Simultaneous medical interventions:
No interaction with concomitant pharmacological treatments and / or medical interventions simultaneous, apart from those that occur in the usual treatment with any CRT device. All participants will be candidates for the implantation of a CRT device and will be included in the clinical study once the device has been implanted successfully.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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 older than 18 years.
- •Patients who state that they understand the study and are willing to participate in it by signing the corresponding Informed Consent form.
- •Patients who have been implanted with an Abbott Medical ® CRT with SyncAVTM stimulation function under the current ESC Class I or Class II-a indications for the implantation of CRT (including updates from pacemakers or single-chamber or double-chamber of an implantable cardioverter-defibrillator (ICDs)).
- •In sinus rhythm during the Basal visit.
- •Patients with Left Branch Block (LBB) defined as:
- •QRS duration> 120 msec
- •interval (QS) or interval (rS) in V1
- •Single phase R (without Q wave) in V6 and interval (DI)
- •LVEF <35% being under optimal medical treatment
- •PR Baseline <250 ms without BAV of 2nd or 3rd grade.
- •Patients who are willing to meet all the requirements of the study and who have the ability to do it.
排除标准
- •Having suffered myocardial infarction or unstable angina in the 40 days prior to inclusion.
- •NYHA Class IV.
- •Having undergone coronary revascularization (PTCA, Stent or CABG) in the 4 weeks prior to inclusion.
- •Having suffered a cerebrovascular accident (CVA) or a Transient Ischemic Accident (TIA) in the 3 months prior to inclusion.
- •Have a status of 1 for heart transplantation or be evaluated to receive a transplant in the next 12 months.
- •Primary valve disease that requires surgical intervention.
- •2nd or 3rd grade of AV block.
- •PR> 250 ms.
- •Atrial Fibrillation (AF): Persistent AF at the time of inclusion or 30 days before, or permanent FA not treated with ablation of the AV node in the 2 weeks following the implantation of the CRT, or History or incidence of Paroxysmal or Persistent FA in the 30 days prior to inclusion.
- •Patient in whom adequate transthoracic echocardiographic images can not be obtained to establish cardiac output and VI volumes.
- •Have received a heart transplant or are waiting to receive it.
- •Have a life expectancy <6 months.
- •Being pregnant or intending to become pregnant during the study.
- •Inability to comply with the follow-up calendar.
- •Being currently participating in any other clinical study
研究组 & 干预措施
biventricular stimulation (BiV) group
patients with Abbott Medical® CRT implanted with only biventricular stimulation (BiV).
干预措施: Abbott Medical® CRT device with biventricular stimulation (BiV) (Device)
SyncAVTM stimulation group
patients with Abbott Medical® CRT implanted and SyncAVTM stimulation activated
干预措施: Abbott Medical® CRT device with SyncAVTM stimulation function (Device)
结局指标
主要结局
Number of responders patients evaluating the superiority of CRT with ventricular stimulation with fusion using the SyncAV TM algorithm versus BiV conventional stimulation
时间窗: 6 months
The assessment of the main objective must be carried out on a population that has been implanted an Abbott Medical® CRT with SyncAV TM Stimulation function under the current ESC Class I or Class II-a indications for CRT implantation (including pacemaker or single-chamber or dual chamber of an implantable cardioverter defibrillator (DAI) updates
次要结局
- % of patients with AF and AF load(6 months)
- % FA (no patients / FA load)(6 months)
- Inverse remodeling of the LV(6 months)
- NYHA Class Change(6 months)
- Mortality from any cause(6 months)
- Quality of life variable according to KCCQ-12 survey(6 months)
- % of patients who lose the possibility of SyncAV TM (BAV, lengthening of interval (PR) ...)(6 months)
- Comparison of the echocardiographic parameters with the cohort of patients stratified according to the etiology (ischemic patients versus to non-ischemic patients)(6 months)
- Combined mortality and hospitalization variable for heart failure(6 months)
- Number of appropriate / inappropriate discharge in patients(6 months)
- Hospitalization rate for any cause, due to cardiovascular causes and / or heart failure(6 months)