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临床试验/NCT05316753
NCT05316753Unknown不适用

Comparison of Biphasic Truncated Exponential and Pulsed Waveforms for Cardioversion of Atrial Fibrillation-High Energy Escalation Strategy and Introduction to Manual Pressure Application

University National Heart Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
94
试验地点
1
主要终点
Defibrillator Efficacy

研究概览

简要总结

Background: A Danish study raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. Maximal energies are usually the final choice of the physicians. Some authors showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome. This is likely due to the impedance decrease linked to MPA.

Objective: This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines high energy shocks at first shock, jumping to maximal defibrillator energy at second shock and finally complemented by MPA at third shock, if success is not reached using electric shocks only.

Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit, Cardiology Clinic, National Cardiology Hospital (NCH), Sofia, Bulgaria. All eligible patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion.

AF patients will be alternatively randomized to cardioversion using one of the two defibrillators, following the strategy below:

DEFIGARD HD-7 arm: 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MPA LIFEPAK15 arm: 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MPA The statistical power analysis will consider a superiority comparison between the cumulative energy actually delivered by both defibrillators.

The secondary cardioversion efficacy outcome measures are: the cumulative success rate (measured at 1 minute post-shock), number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NCH Ethical Committee). Heart rhythm will be measured in continuously recorded peripheral ECG.

The secondary cardioversion safety outcome measures are: markers for myocardial necrosis (high sensitive troponin I, CK-MB) evaluated on blood samples taken before and 8-12 hours after cardioversion; ST-segment changes (post-shock - pre-shock) measured in lead II; Complications after cardioversion measured during 2 hours follow-up period in the ICCU - the presence of apnea, arrhythmias, bradycardia and the need for respective therapy at the discretion of attending physician.

详细描述

Background Commercially available defibrillators generate direct current (DC) shock with various waveforms using distinct technologies. These waveforms are suggested to have different efficacy and safety. Although the superiority of biphasic over monophasic waveforms is well established, the relative efficacy and safety of the available biphasic waveforms is not clear.

Various BTE waveforms apply different potential gradients on the thorax that might produce various defibrillation effects. Apart from efficacy, the most important aspect is the patient safety, considering that larger potential gradients in the myocardium lasting longer could potentially induce an electroporation and then a fibrillation. A frequently observed effect of electroporation are the post-shock ST-segment deviations in the surface ECG, representing the potential difference between the normal tissue and sustained depolarized critical mass of myocardium closest to the associated origin of the electrical current. Although ST-segment changes are an easily ignored phenomenon, occurring acutely and resolving during the first few minutes post-shock, their presence in a short-term basis can identify electroporation by dangerously high potential gradients, while the sustained ST-changes in a long-term basis can identify cases with myocardial injury. The most reliable marker of shock-induced myocardial injuries is the high sensitive cardiac Troponin I (hsTnI).

In a previous study Trendafilova et al. were compared fixed-high energy protocols (200J-200J-200J) delivered by two different defibrillation waveforms: Pulsed (BTE-PE) and High-energy BTE (BTE-HE). This study concluded on non-inferiority between devices. Cumulative energy, efficiency of the waveforms and safety (measured by High-sensitive Troponin) were not reaching significant difference for both waveforms. Delivered energy of the first efficient shock was significantly lower for BTE-PE and although BTE-PE delivered almost 28J lower energy after the whole procedure, significance could not be reached due to wide variance.

In a Danish study Schmidt et al. compared two cardioversion protocols - one is fixed-high energy (360J-360J-360J), the other is low energy escalating (125J-150J-200J). The overall efficacy of fixed-energy protocol was better than escalating. Safety is non significantly different. Schmidt et al. raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols.

There is an ethical consideration to apply maximal energy shocks to all patients without considering patient individuality. Ramirez et al. remind that failed shocks might depend on other factors like transthoracic impedance. Lavignasse et al. found that cumulative energy setting differs with patient characteristics, having significant association with: AF duration, gender, BSA, LV TDD, valvular disease and chronic respiratory disease. Indeed, some authors (Voskoboinik et al. and Ramirez et al.) showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome.

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
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

  • •Indications for elective cardioversion of atrial fibrillation
  • •Patients > 18 years old and:
  • •Symptomatic AFIB with a duration of less than 12 months and EHRA score 2-4
  • •Symptomatic first detected AFIB and EHRA score 2-4
  • •Persistent AFIB after successful causal therapy
  • •Rare recurrences of AFIB with long periods of sinus rhythm
  • •Impossibility to reach a sustained normal ventricular rate in AFIB

排除标准

  • •Patients with atrial flutter
  • •Spontaneous HR <60/min
  • •Digitalis intoxication
  • •Impossibility to maintain sinus rhythm irrespective to antiarrhythmic therapy and frequent cardioversions
  • •Conduction disturbances (without fascicular block and AV block 1 degree) in patients without pacemaker
  • •Asymptomatic patients with AFIB for > 1 year
  • •Thyroid dysfunction: euthyroid status of at least one month is required (TSH is measured).
  • •Thrombosis in cardiac cavities, assessment performed using Transesophageal echocardiography (TEE)
  • •Spontaneous echo contrast > 2 degree (TEE)
  • •Patients with planned cardiac operation in the next three months
  • •Patients with embolic event in the last three months
  • •Patients <18 years of age
  • •Pregnant woman

研究组 & 干预措施

Schiller Defigard HD- 7 - DGHD7

Experimental

Device: Cardioversion with a pulsed biphasic waveform Cardioversion is performed by a pulsed biphasic (Multipulse Biowave®) waveform (Schiller Defigard HD- 7 - DGHD7, Schiller Medical, France) with adult pads (0-21-0003 Schiller) following an energy protocol of 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MAP (Manual Pressure Application). The protocol is stopped at successfull cardioversion (sinus rhythm at 1 min post-shock), otherwise after the 3rd shock Other Name: DGHD7

干预措施: Cardioversion with a pulsed biphasic waveform (Procedure)

LIFEPAK 15, Physio-Control - LP15

Active Comparator

Device: Cardioversion with a biphasic truncated exponential waveform Cardioversion is performed by a biphasic truncated exponential waveform (LIFEPAK 15, Physio-Control Inc., Redmond, WA, USA) with recommended by the manufacturer adult pads (Redipak QUICK COMBO, Physio-Control) following an energy protocol of 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MAP (Manual Pressure Application). The protocol is stopped at successfull cardioversion (sinus rhythm at 1 minute post-shock), otherwise after the 3rd shock.

Other Name: LP15

干预措施: Cardioversion with a biphasic truncated exponential waveform (Procedure)

结局指标

主要结局

Defibrillator Efficacy

时间窗: Delivered energy (Joules) will be measured during each shock with a dedicated pulse recording device

The cumulative delivered energy by the consecutive defibrillation shocks during the successful cardioversion procedure.

次要结局

  • The cumulative success rate (at 24 hours) of the consecutive defibrillation shocks during the cardioversion procedure(Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at twenty four hours after each shock)
  • ST-segment changes after each defibrillation shock(ST-segment will be measured in the continuously recorded lead II 10 seconds after each defibrillation shock (0.080 seconds after J point in the first QRS at 10 seconds post-shock))
  • The cumulative success rate at 1 minute(Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at the first minute after each shock)
  • Number of shocks(During the whole cardioversion procedure, each electrical shock delivered to the patient will be counted)
  • Changes in hsTnI at 8-12 hours(the blood samples will be taken before cardioversion (on the same day) and after cardioversion (from 8 to 12 hours after the intervention))
  • Changes in CK and CK-MB at 8-12 hours(the blood samples will be taken before cardioversion (on the same day) and after cardioversion (from 8 to 12 hours after the intervention))
  • The cumulative success rate (at 2 hours) of the consecutive defibrillation shocks during the cardioversion procedure(Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at two hours after each shock)

研究者

发起方
University National Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elina Trendafilova

professor

University National Heart Hospital

研究点 (1)

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