Catheter Ablation for Atrial Fibrillation

(ARIADNE RCT Trial)

Recruiting at 2 trial locations

Overseen By Kristie Coleman, MPH, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stavros E Mountantonakis

Disqualifiers: Heart failure, Hypertension, Renal failure, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of catheter ablation, a treatment for individuals with persistent atrial fibrillation (a long-term irregular heartbeat). Researchers compare three approaches to determine which one best helps patients remain free from atrial fibrillation for a year. The trial employs a special catheter capable of switching between two types of energy for the ablation. It seeks participants who have experienced atrial fibrillation symptoms lasting longer than a week but less than a year and who have not undergone certain heart surgeries. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment options for atrial fibrillation.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that pulsed field ablation (PFA) is generally safe for treating atrial fibrillation (AF). In a previous study, only 2.3% of patients experienced minor issues, such as inflammation around the heart (pericarditis) or a mild heart attack. Another study with over 17,000 patients found that PFA is safe and causes less damage to nearby tissues compared to older methods.

For the treatment group using PFA for both pulmonary vein isolation and posterior wall isolation, the safety results appear promising. Early studies suggest this method is safe and effective, with lasting results in follow-up procedures.

The group that includes mitral isthmus ablation (a procedure to block abnormal heart signals) uses either PFA or radiofrequency ablation (RFA). Both methods have been found to be safe, with PFA showing fewer side effects.

Overall, treatments in this trial have demonstrated a strong safety record based on earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for atrial fibrillation, which typically involve catheter ablation using radiofrequency (RFA) or cryoballoon techniques, this trial explores the use of pulsed field ablation (PFA) energy. Researchers are excited about PFA because it targets heart tissue more precisely and with less risk of damage to surrounding structures, potentially leading to fewer complications. Another arm of the study combines PFA with posterior wall isolation and mitral isthmus ablation using either PFA or RFA, which might improve the success rates in more complex cases of atrial fibrillation. These innovative methods offer a promising alternative, aiming to enhance safety and effectiveness compared to traditional ablation techniques.

What evidence suggests that this trial's ablation strategies could be effective for atrial fibrillation?

Research has shown that pulsed field ablation (PFA) effectively treats atrial fibrillation, a type of irregular heartbeat. One study found that 84% of patients were free from irregular heartbeats one year after PFA treatment. In this trial, participants may receive pulmonary vein isolation (PVI) using PFA energy alone or PVI with additional treatment to the back wall of the heart, which has demonstrated positive safety and effectiveness. Another group in this trial will receive PVI and posterior wall isolation with the addition of mitral isthmus ablation, using either PFA or another method called radiofrequency ablation (RFA), which also showed good results. PFA has proven safe and effective in treating different areas of the heart, not just the pulmonary veins. Overall, PFA offers a strong chance of reducing or stopping atrial fibrillation. ^{1 2 5 6 7}

Who Is on the Research Team?

Stavros Mountantonakis, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

The ARIADNE trial is for adults aged 18-80 with persistent atrial fibrillation, documented by a physician and ECG, lasting more than 7 days but less than 12 months. Candidates must be suitable for catheter ablation and able to follow the study's procedures. Exclusions include severe lung or heart conditions, recent MI or stroke, BMI over 40, clotting/bleeding issues, drug/alcohol dependency, and other specific medical exclusions.

Inclusion Criteria

I am a good candidate for a procedure to correct heart rhythm.

Willing and able to comply with all baseline and follow-up evaluations for the full length of the study

I have had symptoms of AF for more than 7 days but less than a year, confirmed by a doctor's note and ECG.

Exclusion Criteria

I have a serious lung condition that affects my breathing.

Body mass index >40 kg/m2

I have a significant narrowing of my heart's mitral valve.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo catheter ablation for persistent AF using a lattice-tip catheter with RFA and PFA energy

1 day

1 visit (in-person)

Monitoring

Patients receive an implantable loop recorder for continuous monitoring of AF/AT/AFL recurrence

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Catheter Ablation

Trial Overview This trial tests three strategies of catheter ablation using a lattice-tip catheter that alternates between RFA and PFA energy in patients with persistent atrial fibrillation. It will evaluate if adding posterior wall isolation (PWI) and mitral isthmus ablation improves freedom from atrial fibrillation after twelve months.

How Is the Trial Designed?

Group I: PVI using PFA energy Active Control 1 Intervention

Pulmonary vein isolation using PFA energy

Group II: PVI and posterior wall isolation using PFA energy Active Control 1 Intervention

Pulmonary vein isolation and posterior wall isolation using PFA energy

Group III: PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. Active Control 1 Intervention

Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

Who Is Running the Clinical Trial?

Stavros E Mountantonakis

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study of 1,011 patients undergoing pulmonary vein radiofrequency catheter ablation for atrial fibrillation, the overall complication rate was 3.9%, indicating a relatively low incidence of early complications associated with this procedure.

No procedure-related deaths occurred, and while some complications like peripheral vascular issues and cardiac tamponade were noted, they were generally manageable, suggesting that the procedure is safe, especially compared to earlier years of AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Bertaglia, E., Zoppo, F., Tondo, C., et al.[2016]

In a study of 3318 patients with early-stage atrial fibrillation, those who underwent catheter ablation had a significantly lower risk of adverse clinical outcomes, including death, stroke, and heart failure hospitalization, compared to those receiving only medical therapy.

Catheter ablation also led to improved quality of life scores after one year, indicating that it not only reduces serious health risks but also enhances patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation improves outcomes and quality of life in Japanese patients with early-stage atrial fibrillation: A retrospective cohort study. Seki, Y., Fujisawa, T., Ikemura, N., et al.[2022]

In a study analyzing 14,875 atrial fibrillation ablation cases from 2015 to 2017, 7.2% of patients experienced complications, with a notable increase in complications over the years, particularly pericardial issues.

Key predictors of complications included older age, female gender, pulmonary hypertension, and chronic kidney disease, while hospitals with higher procedural volumes had lower complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. Wu, L., Narasimhan, B., Ho, KS., et al.[2022]

A study of 86 patients with pacemakers and defibrillators undergoing atrial fibrillation (AF) ablation showed that the procedure is safe, with no significant changes in device function or increased complication rates compared to a control group.

The efficacy of AF ablation was similar in both groups, with recurrence rates of AF at 12 months being 19% for patients with devices and 21% for controls, indicating that AF ablation can be effectively performed in patients with implanted cardiac devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of radiofrequency energy catheter ablation of atrial fibrillation in patients with pacemakers and implantable cardiac defibrillators. Lakkireddy, D., Patel, D., Ryschon, K., et al.[2016]

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]

Radiofrequency ablation is becoming a recognized curative treatment for atrial fibrillation that does not respond to antiarrhythmic drugs, but it carries significant risks due to the complexity of the procedure.

The paper emphasizes the importance of understanding potential complications and prevention techniques to enhance the safety and success rates of catheter ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nightmares in atrial fibrillation ablation--identification, management, and prevention of complications in radiofrequency ablation of atrial fibrillation]. Martinek, M., Pürerfellner, H.[2021]

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 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 72 patients undergoing catheter ablation for atrial fibrillation, the use of a non-fluoroscopic navigation system significantly reduced fluoroscopy exposure (15.4 minutes vs. 21.3 minutes) and overall procedural time (52 minutes vs. 61 minutes) compared to traditional methods.

Both groups achieved similar success rates in being arrhythmia-free after the procedure, with 74% in the non-fluoroscopic group and 78% in the control group, indicating that the new navigation system is effective without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. Rotter, M., Takahashi, Y., Sanders, P., et al.[2022]

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation The first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725059911

Pulsed Field Ablation for Persistent Atrial Fibrillation The first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10803044/

Posterior wall ablation by pulsed-field ablation: procedural ... Posterior wall ablation with this pentaspline PFA catheter can be safely and efficiently performed with a high durability observed during redo procedures.

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02536-0/fulltext

1-Year outcomes of the first-in-human PULSE-EU trial Herein, we present the data on lesion durability, safety, and 12-month effectiveness outcomes using an upgraded version of the spherical array ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.064959

Safety and Effectiveness of Pulsed Field Ablation to Treat ... Beyond the favorable safety profile, the first-in-human PFA trials demonstrated good effectiveness: the 1-year freedom from recurrent atrial arrhythmias was ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.074485

Pulsed Field Ablation for Persistent Atrial Fibrillation There are sparse high-quality safety and effectiveness data for pulsed field ablation (PFA) of persistent atrial fibrillation (PerAF), ...

7. nature.com nature.com/articles/s41591-024-03114-3

Safety of Pulsed Field Ablation in 17,000+ AF Patients These data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation.