617 Participants Needed

Catheter Ablation for Atrial Fibrillation

(STARAF3 Trial)

Recruiting at 34 trial locations
MM
CG
Overseen ByCaroline Girard
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must be taking: Antiarrhythmics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial compares three methods of using a catheter to treat patients with persistent atrial fibrillation (AF). The methods involve creating small scars in different parts of the heart to stop abnormal heart rhythms. The goal is to find out which method works best for these patients. Catheter ablation is increasingly being used to treat patients with atrial fibrillation, with recent studies reporting success rates over 70% for persistent AF.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves patients whose AF has been refractory to at least one antiarrhythmic drug, you might need to continue some medications. Please consult with the trial coordinators for specific guidance.

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

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

What data supports the idea that Catheter Ablation for Atrial Fibrillation is an effective treatment?

The available research shows that Catheter Ablation, specifically Pulmonary Vein Antrum Isolation (PVAI), is a widely used treatment for atrial fibrillation. It is considered effective, especially for patients whose condition does not improve with medication. However, the effectiveness can vary. For example, one study found that PVAI is less effective in patients with persistent atrial fibrillation and a large left atrium. Another study highlighted that while PVAI is effective, it can be a complex procedure with long durations and high exposure to X-rays. Despite these challenges, PVAI remains a primary strategy for treating atrial fibrillation, with ongoing research into improving its outcomes.12345

What data supports the effectiveness of the treatment Pulmonary Vein Antrum Isolation (PVAI) for atrial fibrillation?

Research shows that Pulmonary Vein Antrum Isolation (PVAI) is a key treatment for atrial fibrillation, especially when other medical therapies don't work. It has been found effective, although it can be complex and time-consuming, and its success may vary depending on the patient's condition, such as the size of the left atrium.12345

What safety data is available for catheter ablation in atrial fibrillation treatment?

The safety data for catheter ablation, specifically pulmonary vein antrum isolation (PVAI), indicates that it is an effective treatment for atrial fibrillation. However, the procedure is complex, leading to long procedure times and high fluoroscopy exposure. A comprehensive radiation safety program can reduce radiation exposure for both patients and operators. The clinical outcomes of PVAI may be less satisfactory in patients with persistent atrial fibrillation and a large left atrium.12367

Is catheter ablation for atrial fibrillation safe?

Catheter ablation, including pulmonary vein antrum isolation (PVAI), is generally considered safe for treating atrial fibrillation, but it involves long procedure times and exposure to radiation. A comprehensive safety program can help reduce radiation exposure for both patients and medical staff.12367

Is the treatment Pulmonary Vein Antrum Isolation (PVAI) promising for atrial fibrillation?

Yes, Pulmonary Vein Antrum Isolation (PVAI) is a promising treatment for atrial fibrillation. It is considered a key method for treating this heart condition, and studies show it can be effective in managing symptoms and reducing recurrence of arrhythmia.12358

How is the treatment Pulmonary Vein Antrum Isolation (PVAI) for atrial fibrillation different from other treatments?

Pulmonary Vein Antrum Isolation (PVAI) is unique because it focuses on isolating the pulmonary veins to prevent erratic electrical signals that cause atrial fibrillation, and it can be combined with additional techniques like box isolation or driver ablation for enhanced effectiveness. This approach is particularly notable for its use in patients who do not respond to medication, although it can involve long procedure times and high exposure to X-rays.12358

Research Team

Atul Verma, MD — AFS 2025

Atul Verma, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

LM

Laurent Macle, MD

Principal Investigator

Montreal Heart Institute

Eligibility Criteria

This trial is for adults over 18 with persistent atrial fibrillation (AF) lasting more than 3 months but less than three years, who have symptoms like palpitations or shortness of breath. They must have tried at least one antiarrhythmic drug without success and be willing to consent to the study. People can't join if they're pregnant, have paroxysmal AF, a low stroke risk score (CHA2DS2-VASc score of 0), an episode shorter than 3 months or longer than 3 years, or a very large left atrium.

Inclusion Criteria

My atrial fibrillation didn't improve with at least one medication.
I am having my first ablation procedure for atrial fibrillation.
I have felt symptoms of AF, like palpitations or shortness of breath, in the last 5 years.
See 4 more

Exclusion Criteria

My AFib episodes don't last more than 7 days.
Your left atrial diameter is larger than 60 mm when seen from a certain position.
I have had atrial fibrillation episodes lasting more than 3 years.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation using one of three strategies: PVAI, PVAI+drivers, or PVAI+box

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with quality of life assessments at 6, 12, and 18 months

18 months
3 visits (in-person)

Treatment Details

Interventions

  • Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
  • Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
  • Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Trial OverviewThe study compares three ablation techniques for treating persistent AF: isolating the pulmonary vein area alone (PVAI), PVAI plus targeting 'drivers' that may cause AF, and PVAI plus isolation of the heart's posterior wall. All methods use advanced catheter technology with cooling tips and sensors.
Participant Groups
3Treatment groups
Active Control
Group I: PV antral isolation plus ablation of driversActive Control1 Intervention
PV antral isolation plus ablation of drivers (PVAI+drivers)
Group II: PV antral isolation plus isolation of posterior wallActive Control1 Intervention
PV antral isolation plus isolation of LA posterior wall (PVAI+Box)
Group III: PV antral isolation alone (PVAI)Active Control1 Intervention
PV antral isolation alone (PVAI)

Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box) is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as PVAI+box for:
  • Persistent Atrial Fibrillation
🇺🇸
Approved in United States as PVAI+box for:
  • Persistent Atrial Fibrillation

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Montreal Heart Institute

Collaborator

Trials
125
Recruited
85,400+

Findings from Research

In a study of 385 patients undergoing pulmonary vein antrum isolation (PVAI) for atrial fibrillation, 42% experienced late arrhythmia recurrences, with a significantly lower rate in patients with paroxysmal atrial fibrillation (39%) compared to those with persistent forms (56%).
Factors such as having non-paroxysmal atrial fibrillation, hypertension, and previous failures of antiarrhythmic drugs were associated with a higher likelihood of arrhythmia recurrence after PVAI, with early recurrences being the strongest predictor of later recurrences.
Clinical predictors of arrhythmia recurrences following pulmonary vein antrum isolation for atrial fibrillation: predicting arrhythmia recurrence post-PVAI.Khaykin, Y., Oosthuizen, R., Zarnett, L., et al.[2011]
In a study of 89 patients with persistent atrial fibrillation (AF) and a large left atrium, no significant differences in recurrence rates of atrial arrhythmia were found among those treated with radiofrequency ablation (RFCA), cryoballoon ablation (CBA), or thoracoscopic maze surgery after 12 months.
Early recurrence of AF during the initial 90-day period was a significant predictor of later recurrence for RFCA and CBA, but this was not the case for the thoracoscopic maze procedure, suggesting different prognostic implications based on the type of intervention.
Catheter ablation and thoracoscopic ablation in long persistent atrial fibrillation with large left atrium.Park, CS., Choi, EK., Lee, SR., et al.[2022]
Using a magnetic-based 3-D mapping system for pulmonary vein antrum isolation (PVAI) in atrial fibrillation significantly reduced procedure time, fluoroscopy exposure, and radiofrequency energy delivery compared to a current-based system and fluoroscopy alone, based on data from 433 patients across three groups.
Despite the differences in procedural efficiency, the study found no significant differences in long-term clinical outcomes or recurrence rates among the different mapping techniques, indicating that while the magnetic system improves efficiency, it does not compromise patient safety or effectiveness.
CARTO-guided vs. NavX-guided pulmonary vein antrum isolation and pulmonary vein antrum isolation performed without 3-D mapping: effect of the 3-D mapping system on procedure duration and fluoroscopy time.Khaykin, Y., Oosthuizen, R., Zarnett, L., et al.[2022]

References

Clinical predictors of arrhythmia recurrences following pulmonary vein antrum isolation for atrial fibrillation: predicting arrhythmia recurrence post-PVAI. [2011]
Catheter ablation and thoracoscopic ablation in long persistent atrial fibrillation with large left atrium. [2022]
CARTO-guided vs. NavX-guided pulmonary vein antrum isolation and pulmonary vein antrum isolation performed without 3-D mapping: effect of the 3-D mapping system on procedure duration and fluoroscopy time. [2022]
Early experience with robotic navigation for catheter ablation of paroxysmal atrial fibrillation. [2009]
Five-year efficacy of pulmonary vein antrum isolation as a primary ablation strategy for atrial fibrillation: a single-centre cohort study. [2017]
Impact of a comprehensive safety program on radiation exposure during catheter ablation of atrial fibrillation: a prospective study. [2018]
Pulmonary vein antrum isolation of pre-excited atrial fibrillation. [2013]
Clinical benefits of deep sedation with a supraglottic airway while monitoring the bispectral index during catheter ablation of atrial fibrillation. [2020]