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Cardioversion for Atrial Fibrillation (QOL-CAFRCT Trial)
N/A
Recruiting
Led By David Birnie, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients age ≥ 18 years
Unknown symptom burden related to AF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
QOL-CAFRCT Trial Summary
This trial will compare quality of life in patients with atrial fibrillation who undergo electrical cardioversion to those who undergo a sham procedure.
Who is the study for?
This trial is for adults over 18 with persistent atrial fibrillation (AF), an irregular heart rhythm, who haven't had their symptoms assessed yet. It's not for pregnant or breastfeeding individuals, those in another clinical trial, unable to consent, with a history of noncompliance to medical therapy, intolerance to Amiodarone, contraindications to anticoagulation, known left-atrial appendage thrombus or prior ablations for AF.Check my eligibility
What is being tested?
The study tests if electrical cardioversion—a procedure that restores normal heart rhythm—improves quality of life compared to a fake (sham) procedure. Participants are randomly assigned to receive either the real treatment or sham and will be monitored for changes in their well-being.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally cardioversion can cause skin irritation where paddles are placed; rare complications may include abnormal heart rhythms. The sham procedure should have no side effects as it mimics the actual process without delivering any treatment.
QOL-CAFRCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am unsure about the symptoms caused by my atrial fibrillation.
Select...
I have ongoing irregular heartbeats.
QOL-CAFRCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference between AFEQT Scores pre and post cardioversion
Secondary outcome measures
Absolute AFEQT score post-cardioversion
Change in daily activity
Change in generic quality of life
+1 moreQOL-CAFRCT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: True cardioversionExperimental Treatment1 Intervention
Following anaesthesia administration, the unblinded team (non-MRP cardiologist / anesthesiologist will open the envelope indicating which arm the patient has been randomized to. Other members of the team will step out of the room. The unblinded non-MRP cardiologist will call out as per usual "All clear", following which a shock is delivered as per the Ottawa Cardioversion Protocol in the 'shock' arm.
Group II: Sham cardioversionPlacebo Group1 Intervention
Following anaesthesia administration, the unblinded team (non-MRP cardiologist / anesthesiologist will open the envelope indicating which arm the patient has been randomized to. Other members of the team will step out of the room. No shock is delivered in the "sham" shock arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical cardioversion
2014
N/A
~440
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,474 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take blood thinners due to health reasons.I am unsure about the symptoms caused by my atrial fibrillation.I have had a procedure to treat atrial fibrillation.I have ongoing irregular heartbeats.I am 18 years old or older.You have a blood clot in your left-atrial appendage.I cannot take Amiodarone due to side effects or health reasons.I cannot or do not want to give permission for treatment.You have a history of not following your doctor's instructions for taking medication.
Research Study Groups:
This trial has the following groups:- Group 1: Sham cardioversion
- Group 2: True cardioversion
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
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