Comparison of Efficacy and Safety of Two Biphasic Defibrillators in Cardioversion of Atrial Fibrillation

NCT04032678 | Completed DMC

• 1 other identifier: P4/10.07.2018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Biphasic truncated exponential (BTE) waveforms are standard for cardiac defibrillation and synchronized cardioversion up to date. BTE waveforms differ by design characteristics and technologies for pulse commutation (rectilinear, standard truncated exponential, pulsed). Clinical evaluation of BTE waveforms can be planned during cardioversion (CVS) as a well-established procedure of atrial fibrillation patients who are able to give consent and also present a more controlled population. Scarce studies have been found to present the relative efficacy and safety of different BTE waveforms during CVS. The validity of significantly deviating results of the pulsed waveform in one CVS study is questionable. Objective: To compare the CVS efficacy and safety two different biphasic defibrillators - a standard truncated exponential waveform and a pulsed biphasic waveform. Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit (ICCU), Cardiology Clinic, University National Heart Hospital (NHH), Sofia, Bulgaria, underwent the pre-CVS medical exams and check for eligibility. All eligible patients will sign a written informed consent prior to the CVS and will receive the standard hospital procedures during CVS, accepted in the NHH, and approved by the NHH Local Ethic Committee. Atrial fibrillation patients will be alternatively randomized to CVS using one of the two defibrillators, following the same energy selection protocol in both defibrillators. The statistical power analysis will consider a non-inferiority comparison between the cumulative energy actually delivered by both defibrillators. The secondary CVS outcome measures are: the cumulative success rate (measured at 1 minute post-shock) and number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NHH Local Ethic Committee). Heart rhythm will be monitoring in continuously recorded peripheral ECG. The secondary CVS safety outcome measures: Biochemical markers for myocardial necrosis (high sensitive troponin I - hsTnI, creatine kinase MB fraction - CK-MB) will be evaluated on blood samples taken before and 12 hours after cardioversion; ST-segment changes will be measured in lead II (baseline and 10 s post-shock) and 12-lead ECG; Complications after cardioversion will be measured during 2 hours follow-up period in the ICCU.

Conditions

Atrial Fibrillation; Arrythmia; Electric Countershock

Keywords

Cardioversion; Cardiac Arrythmias; Myocardial Injury; Defibrillators; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Defibrillator Efficacy - The cumulative delivered energy

  The cumulative delivered energy by consecutive defibrillation shocks during cardioversion. The cumulative delivered energy is the sum of energies delivered by the consecutive shocks, showing the total energy delivered to the body during cardioversion. It is proportional to the total dissipated heat in the heart that is assumed as the major factor for myocardial injury. The cumulative delivered energies of the two defibrillators will be compared.

  At the end of CVS. Delivered energy (Joules) will be measured during each shock with a dedicated pulse recording device

Secondary Outcomes (6)

• Defibrillator Efficacy - The cumulative success rate

  At the end of CVS. 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

• Defibrillator Efficacy - Number of shocks

  At the end of CVS. During the whole cardioversion procedure, each electrical shock delivered to the patient will be counted

• Defibrillator Safety - Changes in the concentration of biochemical markers

  12 hours after CVS +/- 4 hours. The blood samples will be taken before cardioversion (on the same day) and after cardioversion (from 8 to 12 hours after the intervention)

• Defibrillator Safety - Complications after cardioversion

  2 hours after CVS. ECG and close patient attendance will be applied during 2 hours follow-up period in Intensive Cardiology Care Unit

• Defibrillator Safety - ST-segment changes

  At the end of CVS. ST-segment will be measured by a cardiologist in the continuously recorded lead II (immediately before cardioversion and 10s after each shock (80 ms after J point in the first QRS at 10 s post-shock); as well as in standard 12 lead ECG

Study Arms (2)

1 (DGT7)

EXPERIMENTAL

Cardioversion with a pulsed biphasic waveform Cardioversion is performed by a pulsed biphasic (Multipulse Biowave®) waveform (Schiller Defigard Touch 7 - DGT7, Schiller Medical, France) with recommended by the manufacturer adult pads (FRED-PA1, Schiller) following an energy protocol of 3 consecutive shocks with constant selected energy: 200J, 200J, 200J. The protocol is stopped at successful cardioversion (sinus rhythm at 1 minute post-shock), otherwise after the 3rd shock. Primary endpoint: The cumulative energy delivered by the consecutive defibrillation shocks during cardioversion. Other Name: DGT7

Device: Schiller Defigard Touch 7 - DGT7, Schiller Medical, France

2 (LP15)

ACTIVE COMPARATOR

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 constant selected energy: 200J, 200J, 200J. The protocol is stopped at successful cardioversion (sinus rhythm at 1 minute post-shock), otherwise after the 3rd shock. Primary endpoint: The cumulative energy delivered by the consecutive defibrillation shocks during cardioversion. Other Name: LP15

Device: LIFEPAK 15, Physio-Control Inc., Redmond, WA, USA

Interventions

Schiller Defigard Touch 7 - DGT7, Schiller Medical, France DEVICE

Cardioversion with a pulsed biphasic waveform

1 (DGT7)

LIFEPAK 15, Physio-Control Inc., Redmond, WA, USA DEVICE

Cardioversion with a biphasic truncated exponential waveform

2 (LP15)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (indications for elective cardioversion of atrial fibrillation):
• Patients \> 18 years old and:
• Symptomatic AFIB with a duration of less than 12 months - EHRA score 2-4
• Symptomatic first detected AFIB - EHRA score 2-4
• Persistent AFIB after successful causal therapy

You may not qualify if:

• The patients are excluded if one of these conditions is present:
• 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
• Pregnancy

Sponsors & Collaborators

• University National Heart Hospital: lead

Study Sites (1)

University National Heart Hospital

Sofia, 1309, Bulgaria

Location

Related Publications (1)

• Trendafilova E, Dimitrova E, Didon JP, Krasteva V. A Randomized Comparison of Delivered Energy in Cardioversion of Atrial Fibrillation: Biphasic Truncated Exponential Versus Pulsed Biphasic Waveforms. Diagnostics (Basel). 2021 Jun 17;11(6):1107. doi: 10.3390/diagnostics11061107.

  PMID: 34204498 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elina G Trendafilova, MD

  Head of ICCU, NHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This will be a prospective randomized trial (alternating design) where eligible patients will be randomized to treatment with two different defibrillators. Following the order of patient admittance in ICCU-NCH, the attending cardiologist will assign the odd and even eligible patients to the defibrillators in arm 1 and arm 2, respectively. The cardiologist cannot control the order of patient admittance in ICCU-NCH. The alternative randomization design will equalize the number of subjects on each treatment. This study is not designed to control for sex, age, comorbidity, type of device used for cardioversion, cumulative energy delivered during shocks, number of shocks administered. Randomization is performed to limit these and any other confounding factors.

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 25, 2019
• Study Start: February 5, 2019
• Primary Completion: March 30, 2020
• Study Completion: August 6, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

BU (1)