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

390 Participants Needed

Trial Summary

What is the purpose of this trial?

Atrial Fibrillation (AF) is a heart rhythm disturbance that affects over a million people in North America. AF can cause strokes, heart failure, poor quality of life and may lead to premature death. Catheter ablation has been shown to be superior to medications for symptoms, prevention of stroke and heart failure. AF recurrence is a problem after catheter ablation. Our research has found that in most cases AF recurrence occurs because the catheter procedure was ineffective. The objective of our clinical trial is to find out if a new method of performing the catheter procedure will be more effective in preventing AF recurrence compared to the current standard of care ablation procedure. Subjects will be randomly allocated to undergo either the standard of care ablation, or the novel patient tailored ablation. The novel method aims to understand the unique factors responsible for AF in each individual and uses this information to perform a patient-tailored catheter ablation procedure. This is expected to improve the results of AF ablation. The effectiveness and safety of the ablation procedure will be specifically evaluated in women to understand the effect of sex on AF ablation.

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

Cryoballoon ablation is a well-established treatment for atrial fibrillation, showing effectiveness in isolating pulmonary veins, which is crucial for treating this condition. Studies indicate that cryoballoon ablation is effective and safe, with the ability to create consistent lesions and a lower risk of complications compared to other methods. ^{1 2 3 4 5}

Is cryoballoon ablation safe for humans?

Cryoballoon ablation is generally considered safe for treating atrial fibrillation, with benefits like minimal damage to surrounding blood vessels and a lower risk of blood clots. However, real-world data on adverse events is limited, so it's important to discuss potential risks with your doctor. ^{3 4 6 7 8}

How is the treatment for atrial fibrillation in this trial different from other treatments?

This trial uses a personalized approach combining cryoballoon ablation and radiofrequency catheter ablation with EPS guided trigger and substrate ablation, which is unique because it aims to improve the precision and effectiveness of isolating the pulmonary veins, a key area in treating atrial fibrillation. Cryoballoon ablation is a 'single shot' technique that simplifies the procedure compared to traditional methods, potentially reducing complexity and time. ^{1 2 3 5 9}

Research Team

Girish Nair, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Findings from Research

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]

References

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

Atrial fibrillation ablation using cryoballoon technology: Recent advances and practical techniques. [2019]

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

An apparent way of achieving proof of pulmonary vein disconnection during cryoballoon ablation. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Long Term Follow-up of Pulmonary Vein Isolation Using Cryoballoon Ablation. [2016]

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

Cryoballoon catheter ablation in atrial fibrillation. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Advances in cryoballoon technology: benefits and risks in daily practice]. [2022]

6. Japan 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. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation: a meta-analysis of randomized controlled trials. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Treating atrial fibrillation: pulmonary vein isolation with the cryoballoon technique. [2012]

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

Cryoballoon versus radiofrequency catheter ablation of paroxysmal atrial fibrillation: biomarkers of myocardial injury, recurrence rates, and pulmonary vein reconnection patterns. [2022]