60 Participants Needed

Catheter Ablation for Atrial Fibrillation

(ARIADNE RCT Trial)

Recruiting at 2 trial locations
KC
Overseen ByKristie Coleman, MPH, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stavros E Mountantonakis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment Catheter Ablation for Atrial Fibrillation?

Research shows that catheter ablation can improve the quality of life and reduce the risk of heart failure and death in patients with atrial fibrillation. It is often more effective than antiarrhythmic drugs, especially for those who have not responded well to medication.12345

Is catheter ablation generally safe for humans?

Catheter ablation for atrial fibrillation is generally considered safe, but it does carry some risks, especially since it is a complex procedure. Studies have shown that there can be complications, particularly in patients with other heart conditions, but understanding and managing these risks can help improve safety.678910

How does catheter ablation differ from other treatments for atrial fibrillation?

Catheter ablation is a unique treatment for atrial fibrillation because it involves using a thin tube (catheter) to deliver energy to the heart tissue, creating small scars that help restore a normal heart rhythm. Unlike antiarrhythmic drugs, which are often used first, catheter ablation directly targets the heart's electrical pathways and is typically considered when medications are not effective.24111213

What is the purpose of this trial?

A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.

Research Team

SM

Stavros Mountantonakis, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.
I have a history of abnormal blood clotting or bleeding.
I cannot take blood thinners for a long time due to a health condition.
See 29 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Active Control
Group I: PVI using PFA energyActive Control1 Intervention
Pulmonary vein isolation using PFA energy
Group II: PVI and posterior wall isolation using PFA energyActive Control1 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 Control1 Intervention
Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stavros E Mountantonakis

Lead Sponsor

Trials
1
Recruited
60+

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.
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 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.
Catheter ablation for atrial fibrillation is associated with lower incidence of heart failure and death.Modin, D., Claggett, B., Gislason, G., 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.
[Catheter ablation of atrial fibrillation : Status quo].Jilek, C., Lewalter, T.[2020]

References

Catheter Ablation of Atrial Fibrillation in Heart Failure: from Evidences to Guidelines. [2021]
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 for atrial fibrillation is associated with lower incidence of heart failure and death. [2021]
[Catheter ablation of atrial fibrillation : Status quo]. [2020]
Catheter ablation improves outcomes and quality of life in Japanese patients with early-stage atrial fibrillation: A retrospective cohort study. [2022]
Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. [2022]
Population-level evaluation of complications after catheter ablation in patients with atrial fibrillation and heart failure. [2020]
Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. [2016]
[Nightmares in atrial fibrillation ablation--identification, management, and prevention of complications in radiofrequency ablation of atrial fibrillation]. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety and efficacy of radiofrequency energy catheter ablation of atrial fibrillation in patients with pacemakers and implantable cardiac defibrillators. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Real-world outcomes, complications, and cost of catheter-based ablation for atrial fibrillation: an update. [2018]
Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Cost-effectiveness of catheter ablation for atrial fibrillation. [2006]
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