Personalized Catheter Ablation for Atrial Fibrillation

(AWARE-2 Trial)

Recruiting at 1 trial location

Overseen By Sonya Jancar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: Immunosuppressants

Disqualifiers: Persistent AF, Heart failure, others

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

Compensation: Varies

Number of Visits: 6

Duration: On day of ablation

556 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat atrial fibrillation (AF), a heart rhythm issue that can cause serious health problems like strokes and heart failure. The goal is to determine if personalized catheter ablation, a procedure to restore normal heart rhythm, can better prevent AF recurrence compared to the standard method. Participants will be randomly assigned to receive either the standard ablation or the new personalized version, which includes cryoballoon ablation or radiofrequency catheter ablation with EPS-guided trigger and substrate ablation. The study focuses on understanding how the treatment works in women. Ideal candidates are those who have experienced at least two episodes of AF documented in the past year. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to more effective AF treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant therapy, you may need to stop it three months before and after the procedure.

What prior data suggests that this new catheter ablation method is safe for atrial fibrillation patients?

Research has shown that both radiofrequency and cryoballoon ablation treatments are generally safe for treating atrial fibrillation (AF). One study found that radiofrequency ablation had a very low complication rate, with deaths being extremely rare at just 0.05%. Another study reported that 81.6% of patients were free from AF one year after undergoing radiofrequency ablation.

Cryoballoon ablation also appears safe, with few complications reported. After one year, 78% of patients remained free from AF. Studies comparing the two treatments have found similar safety and success rates. Notably, cryoballoon ablation had a 50% lower risk of certain complications compared to radiofrequency ablation.

Overall, these procedures are generally safe for most people, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for atrial fibrillation because they offer a more personalized approach compared to standard options like traditional catheter ablation or antiarrhythmic drugs. Radiofrequency catheter ablation in this study is enhanced with electrophysiological testing, allowing for tailored ablation of specific heart areas that trigger arrhythmias. This precise targeting could potentially lead to better outcomes by addressing individual patient needs. Meanwhile, cryoballoon ablation provides a more uniform application of cold energy to isolate pulmonary veins, which may result in fewer complications and a quicker procedure. These innovations could lead to more effective and safer treatments for atrial fibrillation.

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

Research shows that both cryoballoon ablation and radiofrequency catheter ablation are promising treatments for atrial fibrillation (AF), a condition that causes irregular heartbeats. In this trial, participants will be assigned to one of two treatment arms. One arm will receive cryoballoon ablation, which studies have found keeps about 79% of patients free from AF symptoms after one year. The other arm will receive radiofrequency catheter ablation, which helps about 81.6% of patients avoid irregular heartbeats after a year. Both treatments effectively reduce the return of AF, which is important for preventing strokes and improving quality of life. These findings suggest that these treatments could be good options for managing AF. ^{1 6 7 8 9}

Who Is on the Research Team?

Girish Nair, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for adults who've had at least two episodes of a heart rhythm issue called Atrial Fibrillation in the past year. They must be able to consent and have no severe kidney disease, life expectancy under one year, or conditions like significant valve disease. Pregnant individuals or those with certain heart procedures or diseases are excluded.

Inclusion Criteria

You have had a specific type of irregular heart rhythm confirmed by different heart monitoring tests.

I have had at least two episodes of AF in the last year.

Subjects must be able to provide informed consent

Exclusion Criteria

You already have paralysis in one side of your diaphragm.

You have been diagnosed with certain heart rhythm problems before joining the trial.

I do not have major birth-related heart issues, except for a patent foramen ovale.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation using either the standard cryoballoon ablation or the novel RF based WACA ± electrophysiological testing guided ablation

On day of ablation

1 visit (in-person)

Blanking Period

Atrial tachyarrhythmias are documented but not considered treatment failures

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits and ILR interrogation

24 months

5 visits (in-person) at 2, 6, 12, 18, and 24 months

Long-term Follow-up

Participants are monitored for long-term outcomes including quality of life and recurrence of AF, AFl, or AT

760 days

What Are the Treatments Tested in This Trial?

Interventions

• Cryoballoon ablation
• Radiofrequency catheter ablation +EPS guided trigger and substrate ablation

Trial Overview The study compares two ways to treat Atrial Fibrillation: the standard ablation procedure versus a new patient-tailored method that uses individual-specific information to prevent AF recurrence. Participants will be randomly assigned to either treatment group.

How Is the Trial Designed?

Group I: RF based WACA ± EP testing guided ablation of non-PV triggers of AF and low voltage area ablation Experimental Treatment 1 Intervention

Radiofrequency wide area circumferential ablation (WACA) ± electrophysiological testing guided ablation of non-pulmonary vein triggers of AF and low voltage area ablation

Group II: Cryoballoon ablation Active Control 1 Intervention

Cryoballoon Pulmonary Vein Isolation-Wide area circumferential ablation (WACA)

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Published Research Related to This Trial

In a review of 320 adverse events related to cryoballoon catheter use for pulmonary vein isolation over 10.7 years, the most common issue was phrenic nerve palsy, occurring in 48% of cases, followed by cardiac perforation at 15%.

All reported intra-procedural deaths were linked to cardiac perforation, highlighting a significant safety concern associated with this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience. Tan, MC., Tan, JL., Lee, WJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5135165/

Outcomes Of Cryoballoon Ablation Of Atrial Fibrillation [18] While 97% of the targeted PVs were successfully isolated, freedom from AF was only 56% at 1 year. Though in this study the longterm clinical efficacy ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824004173

Effectiveness of cryoballoon ablation for atrial fibrillation in ... At 12 months, the rates of AF recurrence did not differ significantly between the LCPV variant group (17.6%) and the standard anatomy group (11.1%) (P = .09), ...

3. journals.lww.com journals.lww.com/cd/fulltext/2022/09000/long_term_outcomes_after_second_generation.4.aspx

Long-term Outcomes after Second-Generation Cryoballoon... The STOP AF PAS study showed that CB2 ablation in patients with PAF was effective, with freedom from AF/symptomatic AFL/AT in 79.0% of patients at 12 months, ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.042622

Cryoballoon or Radiofrequency Ablation for Atrial ... In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2029554

Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation In the ablation group, initial success of the procedure was achieved in 97% of patients. The Kaplan–Meier estimate of the percentage of patients ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00193-6/fulltext

In-hospital safety of cryoballoon and radiofrequency ... Multiple randomized controlled trials report conflicting results in comparing both ablation methods.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8727157/

Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation ... At the 12-month follow-up, freedom from AF recurrence was 79.2%, 77.4%, 76.8%, and 75.2% (p=0.21), respectively (with increasing age). At 24-month follow-up, ...

8. tehj.springeropen.com tehj.springeropen.com/articles/10.1186/s43044-025-00611-9

Comparative safety and effectiveness of cryoballoon versus ... The findings indicated a similar success rate in both groups, with 67% (1,147 individuals) in the CBA group and 67.3% (1,128 individuals) in the ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X18308892

Long-Term Outcomes After Ablation for Paroxysmal Atrial ... Freedom from AF was 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months. Freedom from AF and symptomatic atrial flutter/atrial tachycardia was 79.0% ...