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Dual Versus Single Shock for Cardioversion of Atrial Fibrillation

NCT03943693 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-04-07

No results posted yet for this study

Summary

The investigators aim to investigate the immediate success rate (rate of termination of atrial fibrillation) of dual shock cardioversion compared with standard single shock cardioversion in patients with baseline characteristics adversely influencing successful cardioversion. Baseline characteristics known to reduce the success rate of single shock cardioversion include: increased body mass index (BMI), chronic obstructive pulmonary disease, sleep apnea, enlarged left atrium, longer duration of atrial fibrillation and use of amiodarone.

Conditions

Interventions

DEVICE

Double shock

Patients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized. If the first attempt with this approach fails to terminate atrial fibrillation a second attempt will be made using the same approach. If the second attempt fails the dual shock approach will be considered to have failed and further treatment will be determined by the primary team/attending cardiologist.

DEVICE

Single shock

Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only. A repeat attempt will be made using the same approach if the initial shock fails. If the second attempt fails, the single shock approach will be considered to have failed. Patients will be crossed over to dual shock therapy while under the same sedation episode. For cross-over patients, two near-simultaneous 200-Joule shocks will be delivered through the two sets of pads already in position. If this fails further treatment will be determined by the primary team/attending cardiologist.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Deborah Lockwood, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943693 on ClinicalTrials.gov