Early Ablation for Atrial Fibrillation

Recruiting at 4 trial locations

Overseen By Anna-Katharina Quade

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atrial Fibrillation Network

Disqualifiers: Life expectancy <1 year, Pregnancy, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: Throughout study completion, estimated at a mean of 4 years

2312 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 3 11 12 13}

Research Team

Volker Straub

Principal Investigator

Patient representative

Paulus Kirchhof, Prof. Dr.

Principal Investigator

University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf

Jason Andrade, Prof. Dr.

Principal Investigator

University of British Columbia, Vancouver General Hospital, Department of Electrophysiology

André Ng, Prof. Dr.

Principal Investigator

Department of Cardiovascular Sciences, University of Leicester

Prash Sanders, Prof. Dr.

Principal Investigator

Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital

Kevin Vernooy, Prof. Dr.

Principal Investigator

Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)

Andreas Rillig, PD Dr.

Principal Investigator

University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf

Antonia Zapf, Prof. Dr.

Principal Investigator

Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf

Eligibility 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

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

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

Treatment Details

Interventions

• Early Atrial Fibrillation Ablation

Trial Overview 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.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Group II: Early atrial fibrillation ablation Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Atrial Fibrillation Network

Lead Sponsor

Trials

16

Recruited

26,000+

Findings from Research

In a review of six randomized controlled trials involving 1212 patients, catheter ablation as a first-line treatment for atrial fibrillation significantly reduced the recurrence of atrial tachyarrhythmias compared to antiarrhythmic drugs, with a risk ratio of 0.63.

Patients undergoing catheter ablation also experienced fewer symptomatic atrial tachyarrhythmias, while the safety profile showed no significant difference in overall or cardiovascular adverse events between the two treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Catheter Ablation vs Antiarrhythmic Drugs as Initial Therapy for Management of Symptomatic Paroxysmal Atrial Fibrillation: A Meta-Analysis. Razzack, AA., Lak, HM., Pothuru, S., et al.[2022]

In a study of 174 atrial fibrillation patients, those who underwent catheter ablation had significantly lower rates of total mortality (0.74% vs. 2.95% per year) and cardiovascular death (0% vs. 1.77% per year) compared to those who received only medication.

Catheter ablation not only reduced mortality but also the risk of ischemic stroke/transient ischemic attack, highlighting its efficacy in improving long-term cardiovascular outcomes for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful catheter ablation reduces the risk of cardiovascular events in atrial fibrillation patients with CHA2DS2-VASc risk score of 1 and higher. Lin, YJ., Chao, TF., Tsao, HM., et al.[2013]

In a study of 100 patients with symptomatic atrial fibrillation (AF), early catheter ablation (within 1 month) did not show a significant advantage over delayed ablation (after 12 months of optimized medical therapy) in terms of arrhythmia-free survival at 12 months, with 56.3% and 58.6% success rates respectively.

Secondary outcomes, including AF burden and antiarrhythmic drug use, also showed no significant differences between the early and delayed ablation groups, indicating that delaying the procedure does not compromise its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of early vs. delayed atrial fibrillation catheter ablation on atrial arrhythmia recurrences. Kalman, JM., Al-Kaisey, AM., Parameswaran, R., et al.[2023]

In a meta-analysis of 12 studies involving 4962 patients, uninterrupted use of novel oral anticoagulants (NOACs) during atrial fibrillation (AF) ablation was associated with a very low incidence of stroke or transient ischemic attack (TIA), comparable to vitamin K antagonists (VKAs).

NOACs significantly reduced the risk of major bleeding (0.9%) compared to VKAs (2%), indicating that NOACs may be a safer option for anticoagulation in patients undergoing AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated meta-analysis of novel oral anticoagulants versus vitamin K antagonists for uninterrupted anticoagulation in atrial fibrillation catheter ablation. Cardoso, R., Knijnik, L., Bhonsale, A., et al.[2018]

In a study of 25,439 patients who underwent their first direct current cardioversion for atrial fibrillation, catheter ablation (CAF) was linked to a significant reduction in all-cause death and cardiovascular death, with hazard ratios of 0.69 and 0.68, respectively.

CAF was also associated with a lower risk of developing heart failure (HR 0.76), but it did not reduce the risk of stroke or thromboembolism, suggesting that while CAF improves survival outcomes, it may not affect all complications of atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation for atrial fibrillation is associated with lower incidence of heart failure and death. Modin, D., Claggett, B., Gislason, G., et al.[2021]

In a study of 700 patients with atrial fibrillation and heart failure who underwent catheter ablation, only 2.0% experienced major adverse events within 30 days, indicating that the procedure has a relatively low incidence of complications.

Key risk factors for these adverse events included being over 65 years old and having coronary artery disease, suggesting that these patients may need closer monitoring after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-level evaluation of complications after catheter ablation in patients with atrial fibrillation and heart failure. Samuel, M., Abrahamowicz, M., Joza, J., et al.[2020]

In a study of 207 patients undergoing catheter ablation for atrial fibrillation, the use of aspirin and warfarin without low molecular weight heparin was found to be a safe anticoagulation strategy, with only two cases of transient ischemic attack occurring post-procedure.

The protocol involved stopping warfarin three days before the procedure and starting aspirin, then restarting warfarin immediately after, which effectively managed anticoagulation and minimized the risk of thrombi and stroke during the ablation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periprocedural anticoagulation for atrial fibrillation ablation. Mortada, ME., Chandrasekaran, K., Nangia, V., et al.[2008]

The safety and effectiveness of catheter ablation for atrial fibrillation (AF) in routine clinical practice, especially for patients with persistent and long-standing AF, remain uncertain despite positive results from clinical trials.

To address these concerns, a national registry for AF ablation procedures, known as the Safety of Atrial Fibrillation Ablation Registry Initiative, was proposed to monitor outcomes and improve the understanding of this treatment's safety and efficacy in diverse clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Al-Khatib, SM., Calkins, H., Eloff, BC., et al.[2010]

In a study of 2,323 patients undergoing catheter ablation for atrial fibrillation, major complications occurred in 4.0% of cases, with vascular access complications being the most common.

Female patients and those with longer procedure times were found to have a higher risk of complications, indicating that these factors should be considered when assessing patient safety during catheter ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated national multicenter registry on procedural safety of catheter ablation for atrial fibrillation. Bertaglia, E., Stabile, G., Pappone, A., et al.[2014]

Catheter ablation for atrial fibrillation (AF) is becoming more common and effective, with large registries providing valuable data on its methods, safety, and short-term efficacy.

Emerging long-term follow-up studies are beginning to address the impact of catheter ablation on serious outcomes like stroke and death, which are crucial for understanding its overall effectiveness in improving patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome after catheter ablation for atrial fibrillation: safety, efficacy and impact on prognosis. Hunter, RJ., Schilling, RJ.[2010]

In a study of 537 matched pairs of patients, catheter ablation for asymptomatic atrial fibrillation (AF) showed a significantly lower incidence of serious cardiovascular events compared to conservative management, particularly in patients with previous AF-related complications.

The benefits of catheter ablation were notable in high-risk asymptomatic patients (19.2% vs. 55.6% at 8 years), while no significant advantage was observed in asymptomatic patients without prior complications, highlighting the importance of patient history in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic impact of catheter ablation in patients with asymptomatic atrial fibrillation. Kawaji, T., Shizuta, S., Tanaka, M., et al.[2023]

In a study of 678 patients undergoing catheter ablation for atrial fibrillation (AF), 28% experienced AF recurrence within the first 90 days, with half of these recurrences occurring within the first 14 days post-ablation.

Factors such as a history of coronary artery disease, cardioversion during the procedure, and being an older woman were identified as strong predictors of early AF recurrence, while longer P-wave duration at follow-up was associated with these recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of recurrence of atrial fibrillation within the first 3 months after ablation. Zink, MD., Chua, W., Zeemering, S., et al.[2021]

Catheter ablation is a standard and effective treatment for rhythm control in patients with atrial fibrillation (AF), helping to restore normal heart rhythm.

The review covers the latest techniques and technologies used in AF catheter ablation, including different energy forms and procedural methods, ensuring comprehensive understanding for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Catheter ablation of atrial fibrillation : Status quo]. Jilek, C., Lewalter, T.[2020]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Catheter Ablation vs Antiarrhythmic Drugs as Initial Therapy for Management of Symptomatic Paroxysmal Atrial Fibrillation: A Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Successful catheter ablation reduces the risk of cardiovascular events in atrial fibrillation patients with CHA2DS2-VASc risk score of 1 and higher. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Impact of early vs. delayed atrial fibrillation catheter ablation on atrial arrhythmia recurrences. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An updated meta-analysis of novel oral anticoagulants versus vitamin K antagonists for uninterrupted anticoagulation in atrial fibrillation catheter ablation. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Catheter ablation for atrial fibrillation is associated with lower incidence of heart failure and death. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Population-level evaluation of complications after catheter ablation in patients with atrial fibrillation and heart failure. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Periprocedural anticoagulation for atrial fibrillation ablation. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Updated national multicenter registry on procedural safety of catheter ablation for atrial fibrillation. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Long-term outcome after catheter ablation for atrial fibrillation: safety, efficacy and impact on prognosis. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Prognostic impact of catheter ablation in patients with asymptomatic atrial fibrillation. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Predictors of recurrence of atrial fibrillation within the first 3 months after ablation. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

[Catheter ablation of atrial fibrillation : Status quo]. [2020]