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Trial Outcomes & Findings for Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation (NCT NCT05992623)

NCT ID: NCT05992623

Last Updated: 2025-09-22

Results Overview

The frequency of NSR by ECG one minute after a single full output DCCV shock is delivered by either a 200J RBW waveform shock from a Zoll Series R defibrillator or 360J BTE waveform shock from a Lifepak 15 defibrillator

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

546 participants

Primary outcome timeframe

At least 1 minute after shock delivery

Results posted on

2025-09-22

Participant Flow

Participant milestones

Participant milestones
Measure
200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.
360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks.
Overall Study
STARTED
270
276
Overall Study
COMPLETED
270
276
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator
n=270 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.
360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator
n=276 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks.
Total
n=546 Participants
Total of all reporting groups
Age, Continuous
70.1 years
STANDARD_DEVIATION 13.1 • n=270 Participants
68.9 years
STANDARD_DEVIATION 14.1 • n=276 Participants
69.5 years
STANDARD_DEVIATION 13.6 • n=546 Participants
Sex: Female, Male
Female
75 Participants
n=270 Participants
90 Participants
n=276 Participants
165 Participants
n=546 Participants
Sex: Female, Male
Male
195 Participants
n=270 Participants
186 Participants
n=276 Participants
381 Participants
n=546 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Paroxysmal AF
23 Participants
n=270 Participants
31 Participants
n=276 Participants
54 Participants
n=546 Participants
Persistent AF
202 Participants
n=270 Participants
193 Participants
n=276 Participants
395 Participants
n=546 Participants
Long-standing Persistent AF
45 Participants
n=270 Participants
54 Participants
n=276 Participants
99 Participants
n=546 Participants
Prior AF Ablation
37 Participants
n=270 Participants
40 Participants
n=276 Participants
77 Participants
n=546 Participants

PRIMARY outcome

Timeframe: At least 1 minute after shock delivery

The frequency of NSR by ECG one minute after a single full output DCCV shock is delivered by either a 200J RBW waveform shock from a Zoll Series R defibrillator or 360J BTE waveform shock from a Lifepak 15 defibrillator

Outcome measures

Outcome measures
Measure
200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator
n=270 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules)
360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator
n=276 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules)
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
223 Participants
233 Participants

SECONDARY outcome

Timeframe: At least 1 minute after shock delivery

The frequency of NSR by ECG one minute after a first or second full output DCCV shock is delivered using either a 200J RBW waveform shock from a Zoll Series R defibrillator or 360J BTE waveform shock from a Lifepak 15 defibrillator

Outcome measures

Outcome measures
Measure
200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator
n=270 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules)
360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator
n=276 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules)
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock
246 Participants
248 Participants

SECONDARY outcome

Timeframe: At least 1 minute after shock delivery

Population: 24/270 patients failed two consecutive 200J RBW shocks and were eligible for crossover, 2/24 patients exited the protocol prior to crossover. 28/276 patients failed two consecutive 360J shocks from a Lifepak 15 defibrillator and were eligible for crossover, 4/28 patients exited the protocol prior to crossover. Reasons for exiting protocol prematurely included initial conversion followed by reinitiation of AF within 1 minute and intial misinterpretation of atrial flutter as sinus rhythm.

The frequency of NSR one minute after the first or second full output DCCV shock is delivered by a Zoll Series R RBW waveform defibrillator and a Lifepak Series 15/20 BTE waveform defibrillator after crossing over from the alternative defibrillator.

Outcome measures

Outcome measures
Measure
200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator
n=24 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules)
360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator
n=22 Participants
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules)
The Frequency of NSR One Minute After the First or Second Full Output DCCV Shock is Delivered by a Zoll Series R RBW Waveform Defibrillator and a Lifepak Series 15/20 BTE Waveform Defibrillator After Crossing Over From the Alternative Defibrillator.
6 Participants
12 Participants

Adverse Events

200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator

Serious events: 0 serious events
Other events: 127 other events
Deaths: 0 deaths

360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator

Serious events: 0 serious events
Other events: 122 other events
Deaths: 0 deaths

Crossover to 200J RBW Shock After Failed 360J BTE Shock

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Crossover to 360J BTE Shock After Failed 200J RBW Shock

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator
n=270 participants at risk
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules)
360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator
n=276 participants at risk
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules)
Crossover to 200J RBW Shock After Failed 360J BTE Shock
n=24 participants at risk
Participants crossing over to a full output 200J RBW shock from a Zoll defibrillator after 2 failed full output 360J BTE shocks from a Lifepak defibrillator
Crossover to 360J BTE Shock After Failed 200J RBW Shock
n=22 participants at risk
Participants crossing over to a full output 360J BTE shock from a Lifepak defibrillator after 2 failed full output 200J RBW shocks from a Zoll defibrillator
Skin and subcutaneous tissue disorders
Skin erythema
42.6%
115/270 • Number of events 115 • 10 minutes
40.9%
113/276 • Number of events 113 • 10 minutes
79.2%
19/24 • Number of events 19 • 10 minutes
40.9%
9/22 • Number of events 9 • 10 minutes
Cardiac disorders
Bradycardia/Atriventricular block/ASystole
4.4%
12/270 • Number of events 12 • 10 minutes
6.9%
19/276 • Number of events 19 • 10 minutes
0.00%
0/24 • 10 minutes
4.5%
1/22 • Number of events 1 • 10 minutes

Additional Information

Brett D. Atwater MD

Inova Schar Heart and Vascular

Phone: 9192390127

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place