Early Ablation for Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Atrial Fibrillation Network
Disqualifiers: Life expectancy <1 year, Pregnancy, Stroke, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).
The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Early Atrial Fibrillation Ablation?
Research shows that catheter ablation, a procedure used in this treatment, can reduce the risk of heart failure and death in patients with atrial fibrillation. It is also effective in reducing symptoms and may lower the chance of future heart-related issues.
12345Is catheter ablation for atrial fibrillation generally safe?
Research shows that catheter ablation for atrial fibrillation is generally considered safe, but there are concerns about complications, especially in routine clinical practice. Studies have looked at short-term and long-term safety, and efforts like the Safety of Atrial Fibrillation Ablation Registry Initiative aim to better understand and improve safety outcomes.
678910How is Early Atrial Fibrillation Ablation different from other treatments for atrial fibrillation?
Early Atrial Fibrillation Ablation is unique because it involves using a catheter (a thin, flexible tube) to target and destroy small areas of heart tissue that cause irregular heartbeats, potentially offering better outcomes when used early in the treatment process compared to waiting until after other treatments fail.
13111213Eligibility Criteria
This trial is for patients with atrial fibrillation who also have other health conditions that increase their risk of stroke and heart issues (CHA2DS2-VASc score of 4 or higher). Specific eligibility details are not provided, but typically participants must meet certain health standards to be included.Inclusion Criteria
I am a candidate for a specific heart rhythm correction procedure using Medtronic's technology.
Provision of signed informed consent
High comorbidity estimated by CHA2DS2-VASc score of 4 or more
+2 more
Exclusion Criteria
Previous participation in EASThigh-AFNET 11
Participation in another clinical trial, either within the 3 months prior to enrolment or still ongoing (participation in potential sub-studies connected to this trial is permitted)
Pregnant women
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to early atrial fibrillation ablation or usual care
Throughout study completion, estimated at a mean of 4 years
Follow-up
Participants are monitored for cardiovascular events, safety, and changes in cognitive function and quality of life
24 months
Regular follow-up visits at 12 and 24 months
Long-term follow-up
Participants are monitored for progression of AF and primary safety outcomes
Throughout study completion, estimated at a mean of 4 years
Participant Groups
The EASThigh-AFNET 11 study is testing if doing an early procedure called atrial fibrillation ablation can prevent strokes and other heart problems better than the usual care given for high-risk AF patients.
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Group II: Early atrial fibrillation ablationExperimental Treatment1 Intervention
Early Atrial Fibrillation Ablation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Atrial Fibrillation Ablation for:
- Symptomatic atrial fibrillation
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation
🇺🇸 Approved in United States as AF Ablation for:
- Symptomatic atrial fibrillation
- Recurrent atrial fibrillation
- Failed antiarrhythmic drug therapy
🇨🇦 Approved in Canada as Catheter Ablation for AF for:
- Symptomatic atrial fibrillation
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
Atrial Fibrillation NetworkLead Sponsor
References
Efficacy and Safety of Catheter Ablation vs Antiarrhythmic Drugs as Initial Therapy for Management of Symptomatic Paroxysmal Atrial Fibrillation: A Meta-Analysis. [2022]Catheter ablation is an effective treatment for atrial fibrillation (AF), primarily performed in patients who fail antiarrhythmic drugs. Whether early catheter ablation, as first-line therapy, is associated with improved clinical outcomes remains unclear.
Successful catheter ablation reduces the risk of cardiovascular events in atrial fibrillation patients with CHA2DS2-VASc risk score of 1 and higher. [2013]It is not known if successful catheter ablation for atrial fibrillation (AF) improves the patient's long-term cardiovascular outcomes. This study investigated the long-term outcomes and mortality of AF patients at high risk who received antiarrhythmic medication and catheter ablation.
Impact of early vs. delayed atrial fibrillation catheter ablation on atrial arrhythmia recurrences. [2023]Catheter ablation is an effective strategy in atrial fibrillation (AF). However, its timing in the course of management remains unclear. The aim of this study was to determine if an early vs. delayed AF ablation strategy is associated with differences in arrhythmia outcomes during 12-month follow-up.
An updated meta-analysis of novel oral anticoagulants versus vitamin K antagonists for uninterrupted anticoagulation in atrial fibrillation catheter ablation. [2018]Catheter ablation is recommended as a first- or second-line rhythm control therapy for selected patients with atrial fibrillation (AF). There is a wide variability in the periprocedural management of oral anticoagulation in patients undergoing AF ablation.
Catheter ablation for atrial fibrillation is associated with lower incidence of heart failure and death. [2021]Catheter ablation for atrial fibrillation (CAF) improves symptoms, but whether CAF improves outcome is less clear. The purpose of this study was to investigate whether CAF is associated with improved outcome in atrial fibrillation (AF) patients with previous direct current (DC) cardioversion.
Population-level evaluation of complications after catheter ablation in patients with atrial fibrillation and heart failure. [2020]Catheter ablation (CA) has been increasingly used to treat atrial fibrillation (AF) in patients with heart failure (HF), however, its safety at the population-level has not yet been evaluated. To assess the safety of CA in AF-HF patients, the frequency and potential risk factors for adverse events (AEs) within 30 days post-CA were determined.
Periprocedural anticoagulation for atrial fibrillation ablation. [2008]Catheter ablation for atrial fibrillation (AF) can increase risk of left atrial (LA) thrombi and stroke. Optimal periprocedural anticoagulation has not been determined.
Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank. [2010]Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry.
Updated national multicenter registry on procedural safety of catheter ablation for atrial fibrillation. [2014]Despite catheter ablation (CA) becoming an accepted treatment option for symptomatic, drug-resistant atrial fibrillation (AF), safety of this procedure continues to be cause for concern. Aim of the present multicenter registry was to assess the incidence of early CA complications and detect their predictors in a contemporary, unselected AF population
Long-term outcome after catheter ablation for atrial fibrillation: safety, efficacy and impact on prognosis. [2010]Catheter ablation of atrial fibrillation (AF) continues to expand and evolve. Large registries like the worldwide survey have provided insight into methods, safety and efficacy of catheter ablation for AF in the short term, and how these are changing. Long-term follow-up data are also emerging answering important questions about safety and efficacy over subsequent years. A small number of studies have attempted to examine whether catheter ablation of AF impacts on hard end points such as stroke and death and hence improve prognosis. This article reviews the current literature providing insight into these rapidly changing areas.
Prognostic impact of catheter ablation in patients with asymptomatic atrial fibrillation. [2023]Catheter ablation for asymptomatic atrial fibrillation (AF) remains controversial. The aim of the present study was to explore the prognostic impact of catheter ablation in asymptomatic AF patients.
Predictors of recurrence of atrial fibrillation within the first 3 months after ablation. [2021]Freedom from atrial fibrillation (AF) at 1 year can be achieved in 50-70% of patients undergoing catheter ablation. Recurrent AF early after ablation most commonly terminates spontaneously without further interventional treatment but is associated with later recurrent AF. The aim of this investigation is to identify clinical and procedural factors associated with recurrence of AF early after ablation.
[Catheter ablation of atrial fibrillation : Status quo]. [2020]Catheter ablation of atrial fibrillation (AF) is a standard part of treatment with respect to rhythm control. In this article, the authors provide a review of the state-of-the-art knowledge of AF catheter ablation including current indications, possible energy forms, procedural methods and endpoints as well as follow-up and further anticoagulation.