QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)

NCT05136131 | Recruiting DMC

• 1 other identifier: 20210782-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden. Rhythm control strategies in patients with persistent AF include cardioversion back to sinus rhythm with long-term recurrence prevention via anti-arrhythmic drugs (AADs) or catheter ablation. However, many studies of these procedures omit a sham placebo control arm. No atrial fibrillation procedural intervention has been compared to a sham procedure. The cardioversion procedure can easily be compared to a "sham" alternative, as it is non-invasive with an expected response within days-to-weeks. Thus, a cardioversion versus "sham" cardioversion trial will allow us to truly assess the impact of a rhythm-control strategy on QOL. It is hypothesized that cardioversion of atrial fibrillation leads to significant improvement in quality of life (QOL) compared to sham cardioversion. Understanding the true QOL impact of sinus rhythm restoration in patients with persistent AF is of significant importance in guiding strategies for the management of AF. Hence, by evaluating what the true effect of cardioversion on QOL in this blinded study, we can better understand the role of medical management and AF ablation in our patients and assess resource allocation to these procedures.

Conditions

Atrial Fibrillation

Keywords

Quality of life improvement; Electrical cardioversion; Sham cardioversion; Rhythm control; Placebo

Outcome Measures

Primary Outcomes (1)

• Difference between AFEQT Scores pre and post cardioversion

  Atrial fibrillation Quality of Life Survey Patients will be asked: "To help people say how good or bad their state of health has been on average in previous 4 weeks/since intervention we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0. We would like you to indicate on this scale how good or bad your health has been on average on average in previous 4 weeks/since intervention in your opinion. Please do this by drawing a line on the scale."

  4 weeks

Secondary Outcomes (4)

• Absolute AFEQT score post-cardioversion

  4 weeks

• Change in generic quality of life

  4 weeks

• Change in daily activity

  4 weeks

• Study exit questionnaire on patient's perceived well-being

  4 weeks

Study Arms (2)

True cardioversion

EXPERIMENTAL

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.

Procedure: Electrical cardioversion

Sham cardioversion

SHAM COMPARATOR

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.

Other: Sham electrical cardioversion

Interventions

Electrical cardioversion PROCEDURE

Shocks are delivered as per the Ottawa Cardioversion Protocol in the "shock" arm. 1) 200J shock delivered using self-adhesive electrodes in an anteroposterior configuration. 2) 200J shock delivered using self-adhesive electrodes in an anterolateral configuration while applying pressure over the electrodes with disconnected standard handheld paddles. 3) 360J shock delivered using the same technique as in (2). 4) As per the treating physician's discretion.

True cardioversion

Sham electrical cardioversion OTHER

No shock is delivered in the sham procedure arm.

Sham cardioversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age ≥ 18 years
• Persistent atrial fibrillation
• Unknown symptom burden related to AF

You may not qualify if:

• Known left-atrial appendage thrombus
• Prior catheter or surgical ablation for AF
• Intolerance or contraindication to Amiodarone
• Contraindication to appropriate anticoagulation
• Patient is included in another randomized clinical trial
• Patient is unable or unwilling to provide informed consent
• Patient with a history of noncompliance with medical therapy
• Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrolment)
• Breastfeeding
• Patients for whom the investigator believes that the trial is not in the interest of the patient

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (2)

Southlake Health

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• David Birnie, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Knight

CONTACT

613-696-7000; tknight@ottawaheart.ca

Mouhannad Sadek, MD

CONTACT

msadek@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial is a double blind (patient and physician blinded) at the time of cardioversion and during the four weeks of post intervention follow-up. The Informed Consent will clearly outline the importance of maintaining the blind to the patient. The "blinded" team will have no knowledge of treatment allocation. The "blinded" team will review the patient at all FUs and during any unscheduled hospital visits/admissions and will be point of contact for the patient's primary physician. This will include the MRP cardiologist and the study nurse / coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All recruited patients will undergo a 4-week pre-cardioversion phase of medical optimization before randomization. One day prior to day of cardioversion, the patient will be randomized electronically using web-based software to "shock" or "sham shock". The patient will remain blinded during the study period and will be unblended at the end of the study period.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 29, 2021
• Study Start: February 10, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)