Study Summary
This trial will compare quality of life in patients with atrial fibrillation who undergo electrical cardioversion to those who undergo a sham procedure.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 4 weeks
4 weeks
Absolute AFEQT score post-cardioversion
Change in daily activity
Change in generic quality of life
Difference between AFEQT Scores pre and post cardioversion
Study exit questionnaire on patient's perceived well-being
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
True cardioversion
1 of 2
Sham cardioversion
1 of 2
Experimental Treatment
Non-Treatment Group
100 Total Participants · 2 Treatment Groups
Primary Treatment: Electrical cardioversion · Has Placebo Group · N/A
True cardioversion
Procedure
Experimental Group · 1 Intervention: Electrical cardioversion · Intervention Types: ProcedureSham cardioversion
Other
ShamComparator Group · 1 Intervention: Sham electrical cardioversion · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical cardioversion
2014
N/A
~440
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
181 Previous Clinical Trials
91,248 Total Patients Enrolled
23 Trials studying Atrial Fibrillation
6,591 Patients Enrolled for Atrial Fibrillation
David Birnie, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
4 Previous Clinical Trials
3,147 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have ongoing atrial fibrillation.
We don't know how much your symptoms are related to atrial fibrillation.
Frequently Asked Questions
Are there vacancies remaining in this clinical assessment?
"According to the clinicaltrials.gov records, this trial is not actively seeking patients; it was first posted on December 20th 2022 and last edited November 18th 2022. Nonetheless, there are currently 477 different studies that are open for enrollment right now." - Anonymous Online Contributor
Unverified Answer