Catheter Ablation for Atrial Fibrillation

(REAL-AF Trial)

Recruiting at 63 trial locations

Overseen By Jennifer White, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

Disqualifiers: Long-standing AF, 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: Unknown

15000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the real-world use of catheter ablation, a procedure that uses heat to treat the heart, for individuals with certain types of atrial fibrillation (AF), an irregular heartbeat. The trial aims to assess the procedure's long-term effectiveness, safety, and efficiency for patients with paroxysmal AF (which stops on its own within 7 days) or persistent AF (lasting more than 7 days). It seeks participants who experience noticeable AF symptoms and are deemed suitable candidates for this treatment by their doctor. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants the opportunity to contribute to its potential availability for wider use.

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 team or your doctor.

What prior data suggests that these radiofrequency technologies are safe for atrial fibrillation ablation?

Research has shown that catheter ablation for atrial fibrillation (AF) is generally safe. A large study found that deaths related to the procedure were extremely rare, at just 0.05% over five years. Another analysis demonstrated that a newer method, pulsed field ablation, had fewer complications compared to older methods using heat. In one group, only a small number of patients (0.4%) experienced a temporary nerve injury, and they left the hospital without any problems.

These findings suggest that most patients handle catheter ablation well. While some risks exist, they are uncommon and usually not serious. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Catheter ablation is unique because it directly targets the faulty electrical pathways in the heart that cause atrial fibrillation (AF). Unlike medications, which often aim to control the heart rate or rhythm, catheter ablation offers a more permanent solution by eliminating the source of the irregular heartbeat. Researchers are excited about this treatment because it has the potential to provide long-lasting relief from AF symptoms and reduce the need for ongoing medication. This technique also minimizes the risk of AF recurrence, making it a promising option for patients seeking a more definitive solution.

What evidence suggests that catheter ablation might be an effective treatment for atrial fibrillation?

Studies have shown that catheter ablation, the treatment under study in this trial, effectively treats atrial fibrillation (AF). In the CABANA study, AF recurrence decreased by 48% over four years following the procedure. Another study found that 52.4% of patients remained free from AF after one year without additional medication. Furthermore, catheter ablation significantly reduced the risk of death in patients with both AF and heart failure. These results suggest that catheter ablation can be a promising treatment for managing AF and improving patient outcomes. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF

De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry

Able and willing to participate in baseline and follow up evaluations for the full length of the registry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-ablation Assessment

Pre-ablation assessments including TTE, CHADS2Vasc, sleep apnea, AAD status, OAC, and medical history

Within 6 months of procedure

Procedure

Catheter ablation procedure using novel RF technologies

Post-procedure Monitoring

Monitoring for acute and late onset complications, including 96-hour continuous heart rhythm monitoring

10-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physician evaluations and arrhythmia assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Catheter Ablation

How Is the Trial Designed?

Group I: Patients with atrial fibrillation Experimental Treatment 1 Intervention

Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Catheter Ablation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Pulmonary Vein Isolation (PVI) for:

• Symptomatic paroxysmal or persistent atrial fibrillation
• Heart failure with reduced left ventricular fraction

Approved in United States as Pulmonary Vein Isolation (PVI) for:

• Symptomatic paroxysmal or persistent atrial fibrillation
• Heart failure with reduced left ventricular fraction

Approved in Canada as Pulmonary Vein Isolation (PVI) for:

• Symptomatic paroxysmal or persistent atrial fibrillation
• Heart failure with reduced left ventricular fraction

Who Is Running the Clinical Trial?

Heart Rhythm Clinical and Research Solutions, LLC

Lead Sponsor

Trials

8

Recruited

20,100+

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460603/

The Effectiveness of Ablation Therapy for Atrial Fibrillation The initial results of the CABANA study revealed a noteworthy reduction of 48% in AF recurrence during a 48-month observation period [7,12].

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2800186

Effect of Catheter Ablation Using Pulmonary Vein Isolation ... After 12 months, 89 patients (52.4%) assigned to PVI with PWI were free from recurrent atrial arrhythmia without antiarrhythmic medication after ...

3. ahajournals.org ahajournals.org/doi/10.1161/circep.114.001672

Five-Year Follow-Up After Catheter Ablation of Persistent ... In 28 patients (5.7%), AF converted to SR with PVI. During index procedures, 148 of 493 patients (30%) showed ATs as consecutive arrhythmia (including right ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1547527124025645

Ablation of Atrial Fibrillation Long-term clinical outcomes ... The purpose of this study was to compare the long-term (36-month) clinical efficacy, quality of life, and cost-effectiveness of SA and CA in LSPAF.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1707855

Catheter Ablation for Atrial Fibrillation with Heart Failure Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death.

6. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.002

Atrial Fibrillation Ablation: Safety in Numbers∗ Deaths associated with atrial fibrillation ablation were very rare, at 0.05% over the last 5-year reporting interval. Additionally, Benali et al ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10626185/

Safety and acute efficacy of catheter ablation for atrial ... The results of this meta-analysis show that there are significantly fewer complications with pulsed field ablation (PFA) compared to thermal ablation. ▫. There ...

8. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00125-0/fulltext

Safety and efficacy of catheter ablation for atrial fibrillation ... Five patients met secondary safety outcomes. In the CB group, 2 patients (0.4%) sustained transient phrenic nerve injury but were discharged the ...

9. ahajournals.org ahajournals.org/doi/10.1161/circep.109.859116

Updated Worldwide Survey on the Methods, Efficacy, and ... The success rate free of AADs was 69.9% in 11 centers performing catheter ablation of paroxysmal AF only, 61.3% in 33 centers performing ...