Radiofrequency catheter ablation +EPS guided trigger and substrate ablation for Atrial Fibrillation

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Ottawa Heart Institute, Ottawa, Canada
Atrial Fibrillation+2 More
Radiofrequency catheter ablation +EPS guided trigger and substrate ablation - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Atrial Fibrillation

Study Summary

This study is evaluating whether a new method of performing the catheter procedure will be more effective in preventing AF recurrence compared to the current standard of care ablation procedure.

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Eligible Conditions

  • Atrial Fibrillation
  • Catheter Ablation, Radiofrequency
  • Catheter Ablation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Radiofrequency catheter ablation +EPS guided trigger and substrate ablation will improve 1 primary outcome and 12 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of 61 to 365 days after ablation.

12 and 24 months
Quality of life SAF scale
Quality of life questionnaire
Quality of life scale
Day 365
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia
760 days
Atrial fibrillation burden
Emergency room visits or hospitalization due to recurrent AF, AFl or AT
Long-term rate of documented AF, AFl or AT
Procedure Related Complications
Repeat catheter ablation for AF, AFl or AT
Day 60
Incidence of any ECG/ILR documented AF, AFl or AT
On day of ablation
Ablation procedure duration
Fluoroscopic exposure
Fluoroscopic exposure dose

Trial Safety

Trial Design

2 Treatment Groups

Cryoballoon ablation
RF based WACA ± EP testing guided ablation of non-PV triggers of AF and low voltage area ablation

This trial requires 390 total participants across 2 different treatment groups

This trial involves 2 different treatments. Radiofrequency Catheter Ablation +EPS Guided Trigger And Substrate Ablation 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.

RF based WACA ± EP testing guided ablation of non-PV triggers of AF and low voltage area ablation
Procedure
Radiofrequency wide area circumferential ablation (WACA) ± electrophysiological testing guided ablation of non-pulmonary vein triggers of AF and low voltage area ablation
Cryoballoon ablation
Procedure
Cryoballoon Pulmonary Vein Isolation-Wide area circumferential ablation (WACA)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 and 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 and 24 months for reporting.

Closest Location

University of Ottawa Heart Institute - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Atrial Fibrillation or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who have paroxysmal AF, or atrial fibrillation that comes and goes, and have had at least two episodes in the past 12 months, are eligible for this study show original
The text says that there must be at least one AF episode that is documented on a 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM), or Loop Recorder. show original
All participants must be at least 18 years old on the date they agree to participate in the trial. show original
Subjects must be able to provide informed consent.

Patient Q&A Section

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

How serious can atrial fibrillation be?

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For those who do not suffer a stroke from atrial fibrillation, the risk of an ischemic stroke or transient ischemic attack is 5-10%/year. For those with a stroke or TIA from atrial fibrillation, the risk of death or further embolic strokes is 1.0-3.8%/year. There is a 25% increased risk of death from any causes after a stroke of atrial fibrillation compared with stroke-free age-matched patients, and a 70% increased risk of death from all causes, including cardiac and noncardiac causes, after atrial fibrillation compared with stroke-free age-matched patients.

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What is atrial fibrillation?

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Atrial fibrillation is a common condition, particularly so in the elderly. It is a type of arrhythmia which is relatively resistant to treatment, with frequent recurrences and a high rate of sudden death.

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

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With the use of this methodology, we estimated that there were more than 650,000 new cases of atrial fibrillation and atypical atrial flutter (AAF) in the United States in 2005. Although the estimates had a low likelihood of error, the number of new AAF cases was similar to that estimated for the U.S. overall at least during the 5-year period 2001-2005. These data also support the use of direct extrapolation method to estimate incidence of atrial fibrillation, for evaluating the burden of AF in the U.S. Results from a recent clinical trial suggested that AF accounts for more than 4% of all cardiovascular hospitalizations in the U.S.

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What are the signs of atrial fibrillation?

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The presence of valvular dysfunction and hypertension in patients with atrial fibrillation were not associated with prolonged fibrillation duration. The presence of a family history of atrial fibrillation and the presence of left ventricular hypertrophy were inversely associated with duration of atrial fibrillation.

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What causes atrial fibrillation?

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As many as 40% of people with AF have no identifiable trigger. However, many of those with identifiable triggers have an underlying disorder that is responsible for this phenomenon. Physicians should consider a thorough medical evaluation when they feel AF may be secondary to another problem(s).

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What are common treatments for atrial fibrillation?

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The most common treatment is anti-arrhythmic drug therapy for atrial fibrillation with or without cardioversion followed by implantation of an cardiac defibrillator, and/or surgical ablation.

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Can atrial fibrillation be cured?

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An important limitation of many of the studies on AF is that they are too recent to address whether AF is cured. The majority of AF patients were treated with anticoagulants, which may have contributed to the reported higher risk of fatal stroke.

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What is the average age someone gets atrial fibrillation?

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Approximately 60% of patients (mean age of 43.2 years) presenting to the emergency department with AF had been symptomatic (nausea, vomiting, chest pain, or shortness of breath) for no more than the past month. Of the remainder, 5.1% were asymptomatic or had only a recent history of AF. If atrial fibrillation develops later in life, the risk of complications increases.

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Have there been other clinical trials involving radiofrequency catheter ablation +eps guided trigger and substrate ablation?

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The present findings indicate that ablation of AF by RF catheter ablation combined with epss guided substrate ablation is safe in terms of the risk of death and of stroke.

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What is the primary cause of atrial fibrillation?

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We found that atrial fibrillation occurs in more hypertensive individuals and more with obesity, with increased resting heart rate and with a higher presence of coronary artery disease.

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What is the latest research for atrial fibrillation?

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The latest research on AF focuses primarily on prevention and treatment strategies. The role that AF-specific genetic variants play in its pathogenesis and treatment remains undefined.

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