BTE and Pulsed Waveforms for Cardioversion of Atrial Fibrillation - Escalation Strategy and Manual Pressure

NCT05316753 | Unknown

• 1 other identifier: UniversityNationalHeartH 1
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

electrical cardioversion

Outcome Measures

Primary Outcomes (1)

• Defibrillator Efficacy

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

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

Secondary Outcomes (7)

• 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

Study Arms (2)

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

Procedure: Cardioversion with a pulsed biphasic waveform

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

Procedure: Cardioversion with a biphasic truncated exponential waveform

Interventions

Cardioversion with a pulsed biphasic waveform PROCEDURE

Cardioversion with a pulsed biphasic waveform

Also known as: Schiller Defigard HD- 7 - DGHD7, Schiller Medical, France

Schiller Defigard HD- 7 - DGHD7

Cardioversion with a biphasic truncated exponential waveform PROCEDURE

Cardioversion with a biphasic truncated exponential waveform

Also known as: LIFEPAK 15 monitor/defibrillator 41577-000267

LIFEPAK 15, Physio-Control - 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University National Heart Hospital: lead

Study Sites (1)

University National Heart Hospital

Sofia, 1309, Bulgaria

RECRUITING

Related Publications (6)

• Lavignasse D, Trendafilova E, Dimitrova E, Krasteva V. Cardioversion of Atrial Fibrillation and Flutter: Comparative Study of Pulsed vs. Low Energy Biphasic Truncated Exponential Waveforms. J Atr Fibrillation. 2019 Oct 31;12(3):2172. doi: 10.4022/jafib.2172. eCollection 2019 Oct-Nov.

  PMID: 32435331 BACKGROUND

• Coats AJS, Anker SD, Baumbach A, Alfieri O, von Bardeleben RS, Bauersachs J, Bax JJ, Boveda S, Celutkiene J, Cleland JG, Dagres N, Deneke T, Farmakis D, Filippatos G, Hausleiter J, Hindricks G, Jankowska EA, Lainscak M, Leclercq C, Lund LH, McDonagh T, Mehra MR, Metra M, Mewton N, Mueller C, Mullens W, Muneretto C, Obadia JF, Ponikowski P, Praz F, Rudolph V, Ruschitzka F, Vahanian A, Windecker S, Zamorano JL, Edvardsen T, Heidbuchel H, Seferovic PM, Prendergast B. The management of secondary mitral regurgitation in patients with heart failure: a joint position statement from the Heart Failure Association (HFA), European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA), and European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur Heart J. 2021 Mar 31;42(13):1254-1269. doi: 10.1093/eurheartj/ehab086.

  PMID: 33734354 BACKGROUND

• Ramirez FD, Sadek MM, Boileau I, Cleland M, Nery PB, Nair GM, Redpath CJ, Green MS, Davis DR, Charron K, Henne J, Zakutney T, Beanlands RSB, Hibbert B, Wells GA, Birnie DH. Evaluation of a novel cardioversion intervention for atrial fibrillation: the Ottawa AF cardioversion protocol. Europace. 2019 May 1;21(5):708-715. doi: 10.1093/europace/euy285.

  PMID: 30535367 BACKGROUND

• Schmidt AS, Lauridsen KG, Torp P, Bach LF, Rickers H, Lofgren B. Maximum-fixed energy shocks for cardioverting atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):626-631. doi: 10.1093/eurheartj/ehz585.

  PMID: 31504412 BACKGROUND

• 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 BACKGROUND

• Voskoboinik A, Moskovitch J, Plunkett G, Bloom J, Wong G, Nalliah C, Prabhu S, Sugumar H, Paramasweran R, McLellan A, Ling LH, Goh CY, Noaman S, Fernando H, Wong M, Taylor AJ, Kalman JM, Kistler PM. Cardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial. J Cardiovasc Electrophysiol. 2019 Feb;30(2):155-161. doi: 10.1111/jce.13786. Epub 2018 Nov 14.

  PMID: 30375104 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Elina G Trendafilova, MD, PhD

  UniversityNationalHeartH, ICCU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elina G Trendafilova, MD, PhD

CONTACT

+359888718847; elitrendafilova@abv.bg

Elena S Dimitrova, MD, PhD

CONTACT

+359887394540; elena.sv@gmail.com

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: professor

Model Details: Randomized Interventional study, Alternating Assignment, Open Label

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 7, 2022
• Study Start: January 20, 2022
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)