Atrial FibrillationNCT05992623
Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation
A study testing Zoll external defibrillator and Lifepak external defibrillator in people with Atrial Fibrillation, run by Inova Health Care Services at 1 site in United States.
Trial summary
The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Zoll external defibrillator and Lifepak external defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area
Who cannot join
- Participants who are receiving any other investigational agents.
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients with arrhythmias other than AF
- Patients with hemodynamically unstable AF
- Patients with untreated hyperthyroidism
- Patients with known or suspected pregnancy
- Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)
The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks
Read the detailed description
Data will be derived from approximately 560 patients arriving to Inova sites of care in Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will be included if they are in AF prior to their procedure and are willing to sign the information sheet and comply with the research procedures. Participants will be excluded if they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Zoll external defibrillator, Lifepak external defibrillator
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoll external defibrillatorDevice
Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
Lifepak external defibrillatorDevice
Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator
| Study group | Role | What they receive |
|---|---|---|
| Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator | Active comparator | Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks. Receives: Device: Zoll external defibrillator |
| Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator | Active comparator | 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. Receives: Device: Lifepak external defibrillator |
| Zoll defibrillator waveform used after unsuccessful second full output shock. | Active comparator | Participants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock. Receives: Device: Lifepak external defibrillator |
| Lifepak defibrillator waveform used after unsuccessful second full output shock. | Active comparator | Participants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock. Receives: Device: Zoll external defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
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
Measured: At least 1 minute after shock delivery
Secondary outcomes (2)
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock
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
Measured: At least 1 minute after shock delivery
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.
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.
Measured: At least 1 minute after shock delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start21 Jul 2023
- Primary completion14 Aug 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to a Zoll or Lifepak defibrillator to perform the DCCV. All shocks will be full output (200J for Zoll shocks and 360J for Lifepak shocks). Follow up will be assessment and documentation of rhythm 1 minute after the last shock is delivered. Participants who do not have first shock success will have a second full output shock ≥1 minute after the first shock. Participants who do not have success after a second full output shock will be crossed over to the other defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett Atwater, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992623
- Sponsor's protocol ID
- U23-04-5042
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2023
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Nguyen AH, Emaminia A, Sandesara C, Ilkhanoff L, Gaeta SA, Lee JJ, Duc J, Fein AS, Held E, Hollis Z, Kumar V, McSwain RL, Lee JC, Arshad A, Rashid H, Wish MH, Yang E, Alkalbani M, O'Connor CM, Atwater BD. Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation. J Am Heart Assoc. 2026 Aug 4;15(15):e042938. doi: 10.1161/JAHA.125.042938. Epub 2026 Jul 25.
PubMed 42500901
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)
- ClinicalTrials.gov ID
- NCT05992623
- Acronym / sponsor ID
- U23-04-5042
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks
Detailed description
Data will be derived from approximately 560 patients arriving to Inova sites of care in Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will be included if they are in AF prior to their procedure and are willing to sign the information sheet and comply with the research procedures. Participants will be excluded if they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized to a Zoll or Lifepak defibrillator to perform the DCCV. All shocks will be full output (200J for Zoll shocks and 360J for Lifepak shocks). Follow up will be assessment and documentation of rhythm 1 minute after the last shock is delivered. Participants who do not have first shock success will have a second full output shock ≥1 minute after the first shock. Participants who do not have success after a second full output shock will be crossed over to the other defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
| Arm | Type | Receives |
|---|---|---|
| Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator | Active comparator | Device: Zoll external defibrillatorParticipants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks. |
| Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator | Active comparator | Device: Lifepak external defibrillatorParticipants 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. |
| Zoll defibrillator waveform used after unsuccessful second full output shock. | Active comparator | Device: Lifepak external defibrillatorParticipants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock. |
| Lifepak defibrillator waveform used after unsuccessful second full output shock. | Active comparator | Device: Zoll external defibrillatorParticipants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area
Key exclusion criteria (7 listed)
- Participants who are receiving any other investigational agents.
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients with arrhythmias other than AF
- Patients with hemodynamically unstable AF
- Patients with untreated hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoll external defibrillatorPatients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator | Device | Lifepak defibrillator waveform used after unsuccessful second full output shock., Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator |
| Lifepak external defibrillatorPatients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator | Device | Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator, Zoll defibrillator waveform used after unsuccessful second full output shock. |
Primary outcome
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
Time frame: 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
2 secondary outcomes
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock
Time frame: At least 1 minute after shock delivery
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.
Time frame: At least 1 minute after shock delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42500901Nguyen AH, Emaminia A, Sandesara C, Ilkhanoff L, Gaeta SA, Lee JJ, Duc J, Fein AS, Held E, Hollis Z, Kumar V, McSwain RL, Lee JC, Arshad A, Rashid H, Wish MH, Yang E, Alkalbani M, O'Connor CM, Atwater BD. Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation. J Am Heart Assoc. 2026 Aug 4;15(15):e042938. doi: 10.1161/JAHA.125.042938. Epub 2026 Jul 25.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Atwater, MD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoll external defibrillator and Lifepak external defibrillator in people with Atrial Fibrillation, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock (time frame: At least 1 minute after shock delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.