Catheter Ablation for Atrial Fibrillation
(STARAF3 Trial)
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?
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
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo catheter ablation using one of three strategies: PVAI, PVAI+drivers, or PVAI+box
Follow-up
Participants are monitored for safety and effectiveness after treatment, with quality of life assessments at 6, 12, and 18 months
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)
Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box) is already approved in European Union, United States for the following indications:
- Persistent Atrial Fibrillation
- 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
Montreal Heart Institute
Collaborator