Trial Outcomes & Findings for Antero-posterior Versus Antero-lateral Electrode Position for Electrical Cardioversion of Typical Atrial Flutter (NCT NCT00860314)

Results Overview

After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

30 seconds after cardioversion

Results posted on

2015-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Antero-Posterior Group Cardioversion with antero-posterior electrode position	Antero-Lateral Group Cardioversion with antero-lateral electrode position
Overall Study STARTED	48	48
Overall Study COMPLETED	48	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antero-posterior Versus Antero-lateral Electrode Position for Electrical Cardioversion of Typical Atrial Flutter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antero-Posterior Group n=48 Participants Cardioversion with antero-posterior electrode position	Antero-Lateral Group n=48 Participants Cardioversion with antero-lateral electrode position	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 12.18 • n=5 Participants	62 years STANDARD_DEVIATION 12.53 • n=7 Participants	62 years STANDARD_DEVIATION 12.29 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment Germany	48 participants n=5 Participants	48 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 seconds after cardioversion

After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.

Outcome measures

Outcome measures
Measure	Antero-Posterior Group n=48 Participants Cardioversion with antero-posterior electrode position	Antero-Lateral Group n=48 Participants Cardioversion with antero-lateral electrode position
Number of Successfully Cardioverted Participants for Each Electrode Position	48 participants	48 participants

SECONDARY outcome

Timeframe: 30 seconds after cardioversion

Outcome measures

Outcome measures
Measure	Antero-Posterior Group n=48 Participants Cardioversion with antero-posterior electrode position	Antero-Lateral Group n=48 Participants Cardioversion with antero-lateral electrode position
Mean Number of Cardioversion Shocks	1.96 Shocks Standard Deviation 1.00	1.48 Shocks Standard Deviation 1.01

SECONDARY outcome

Timeframe: 30 seconds after cardioversion

Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.

Outcome measures

Outcome measures
Measure	Antero-Posterior Group n=48 Participants Cardioversion with antero-posterior electrode position	Antero-Lateral Group n=48 Participants Cardioversion with antero-lateral electrode position
Mean Energy Requirement for Successful Cardioversion	77 Joules Standard Deviation 13	65 Joules Standard Deviation 13

SECONDARY outcome

Timeframe: 30 seconds after cardioversion

Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.

Outcome measures

Outcome measures
Measure	Antero-Posterior Group n=48 Participants Cardioversion with antero-posterior electrode position	Antero-Lateral Group n=48 Participants Cardioversion with antero-lateral electrode position
Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position	17 participants	35 participants

Adverse Events

Antero-Posterior Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Antero-Lateral Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tim Risius, MD

University Hospital Hamburg-Eppendorf, Heart Center

Phone: +49-40-42803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place