CLINICAL TRIAL

Treatment for Atrial Fibrillation

Waitlist Available · 18+ · All Sexes · Saskatoon, Canada

This study is evaluating whether a procedure to remove the atrial fibrillation (AF) source is better than a drug to prevent recurrences.

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About the trial for Atrial Fibrillation

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Anti-Arrhythmic Drug Therapy
DRUG
Control Group 2
Cryoballoon-based PVI
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
Age of 18 years or older on the date of consent
Candidate for ablation based on AF that is symptomatic
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 60 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 60 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of Time to first recurrence between day 0 and 365 post Ablation.

Time to recurrence of symptomatic AF/AFL/AT
TIME TO FIRST RECURRENCE BETWEEN DAY 0 AND 365 POST ABLATION
Time to first recurrence of symptomatic documented AF/AFL/AT between days 91 and 365 after ablation or a repeat ablation procedure between days 0 and 365 post ablation.
Time to recurrence of symptomatic or asymptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia
TIME TO FIRST RECURRENCE BETWEEN DAYS 91 AND 365 POST RANDOMIZATION.
The single procedure success (in the absence of AAD) is defined as the time to first recurrence of symptomatic** or asymptomatic AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) documented by 12-lead ECG, surface ECG rhythm strips, ambulatory ECG monitor, or on implantable loop recorder and lasting 120 seconds or longer as adjudicated by a blinded group of investigators between days 91 and 365 post randomization.
Major complications of ablation, or significant adverse drug events (death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion).
ACUTE PERI-PROCEDURAL COMPLICATIONS WILL BE DEFINED AS OCCURRING WITHIN 30 DAYS OF ABLATION, WITH DELAYED COMPLICATIONS OCCURRING 31-365 DAYS AFTER ABLATION.
Events include events death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion).
Economic Evaluation
TO END OF FOLLOW UP AT 36 MONTHS FOR EACH PATIENT
Incremental cost effectiveness ratio (ICER) for ony QALY gain
Total arrhythmia burden
60 MONTHS
Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is atrial fibrillation?

Frequent atrial fibrillation is a common chronic arrhythmia and, although uncommonly fatal, can require careful management. This can be an easy condition to diagnose given at least six weeks of regular episodes followed by an ECG. Treatment aims at prolonging life and preventing cardiovascular complications, as atrial fibrillation with its associated risk factors is recognized as a form of left ventricular (LV) dysfunction. Treatment typically consists of antiarrhythmic medications with careful surveillance of symptoms and cardiovascular complications. Atrial fibrillation is the leading cause of sudden unexplained death, however it is important to recall that arrhythmia occurs and recurs infrequently.

Anonymous Patient Answer

What are common treatments for atrial fibrillation?

In the European Union, anticholinergic agents (drugs that inhibit the parasympathetic nervous system) are mainly used as the first-line treatment for AF. However, there are currently no well-controlled studies that compare the effectiveness and safety of anticholinergic agents with other types of antiarrhythmic and heart failure therapies in the treatment of AF. This article presents a review of the evidence available for the effectiveness of various non-drug therapies for atrial fibrillation.

Anonymous Patient Answer

What causes atrial fibrillation?

Atrial fibrillation is often traced to a history of trauma or infection, abnormalities of cardiac muscle contraction, or abnormal electrical conduction within the atria. If atrial fibrillation presents with symptoms, the differential diagnosis should exclude this diagnoses with an ECG and cardiac catheterization, and exclude the presence of pulmonary artery hypertension.

Anonymous Patient Answer

Can atrial fibrillation be cured?

Atrial fibrillation is frequently complicated by myocardial infarctions. A randomized clinical trial comparing aspirin versus warfarin in the preventive therapy of atrial fibrillation might be feasible.

Anonymous Patient Answer

What are the signs of atrial fibrillation?

People with AF have long-term mortality and cardiovascular morbidity, including ischemic stroke. Early recognition of AF is challenging, especially in people with noncardiologic manifestations of AF. The most effective diagnostic method is to detect and diagnose concomitant valvular heart disease, but routine cardiac stress testing is required to identify AF. The electrocardiography is essential as a screening tool in patients with AF of at least 3 months duration with risk factors for embolic stroke (age>or =60, CHADS 2 or CHA2DS2-VASc).

Anonymous Patient Answer

How many people get atrial fibrillation a year in the United States?

The prevalence of AF is increasing in most of the world, but the number of new cases per 100,000 population remain low, ranging between 0.7 and 2.0 new cases in the developing world and 3.8-15.0 in the developed world. This suggests that one needs to be cautious about the actual prevalence of AF and its prevalence in other populations of the world. One can, at least, be very cautious about extrapolating prevalence from the United States to countries with less experience in the treatment of AF.

Anonymous Patient Answer

Have there been any new discoveries for treating atrial fibrillation?

In summary, the search for pharmacologic modifiers of the atrial conduction system continues to be largely unsuccessful. There is an urgent need for new and safe interventions for treating the arrhythmia.

Anonymous Patient Answer

What is the primary cause of atrial fibrillation?

Male gender, older age, history of stroke, diabetes and hypertension are the most frequent risk factors for atrial fibrillation in this study. Other risk factors include obesity, myocardial infarction, peripheral vascular disease and previous cardiac surgery. However, the prevalence of the risk factors in patients without atrial fibrillation at presentation suggests that atrial fibrillation is multifactorial.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

The goal of cardioversion, ablation, and defibrillation for cardioversion is to revert a patient's arrhythmia to sinus rhythm. Although reversion of AF to sinus rhythm is always indicated as part of pharmacologic therapy, cardioversion is often used as a primary therapy alone. An important consideration for using cardioversion as a primary therapy is the success rate. Although the success rate depends on the arrhythmia and the severity of the arrhythmia, the success rate is higher if cardioversion is followed by antiarrhythmic therapy. A significant number of patients who need cardioversion as the first step in therapy never have an indication for anti-arrhythmic therapy.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

The use of combination treatment with catheter, antiarrhythmic drugs, anticoagulant medication, mechanical heart valve replacement, or biologics was not found to be strongly influenced by any other treatments and their usage appeared to be relatively independent of any other possible treatments.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

The only group of patients who benefited as much from the placebo pill as from the actual antipyretic (antipyretic) pill were the patients who had previously taken the placebo a long time before. The other two groups did not show any difference in effects. It may be concluded, therefore, from our results that short-term use of an antipyretic drug has no effect, only a placebo effect.

Anonymous Patient Answer

What does treatment usually treat?

If atrial fibrillation is associated with other cardiothoracic diseases (atherosclerosis, structural heart disease), the aim of treatment of atrial fibrillation is to prevent further damage of the heart and minimize risk of embolization. These factors should therefore be considered when assessing the treatment of atrial fibrillation in all patients.

Anonymous Patient Answer
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