Catheter Ablation for Atrial Fibrillation

(STARAF3 Trial)

Recruiting in Palo Alto (17 mi)

+34 other locations

Overseen by Atul Verma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 5 8}

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

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.

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.

Treatment Details

Interventions

• Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box) (Procedure)
• Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers) (Procedure)
• Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI) (Procedure)

Trial Overview The 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

Group I: PV antral isolation plus ablation of drivers Active Control 1 Intervention

PV antral isolation plus ablation of drivers (PVAI+drivers)

Group II: PV antral isolation plus isolation of posterior wall Active Control 1 Intervention

PV antral isolation plus isolation of LA posterior wall (PVAI+Box)

Group III: PV antral isolation alone (PVAI) Active Control 1 Intervention

PV antral isolation alone (PVAI)

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+

Dr. Lucie Opatrny

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

President and Executive Director since 2023

MDCM and Master's in Epidemiology and Biostatistics from McGill University, Master's in Healthcare Management and Diploma in Advanced Negotiation from Harvard University

Dr. Patrizia Cavazzoni

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

Chief Medical Officer

MD from McGill University, residency in Psychiatry and fellowship in Mood Disorders at the University of Ottawa

Montreal Heart Institute

Collaborator

Trials

125

Recruited

85,400+

Dr. Jean-Claude Tardif

Montreal Heart Institute

Chief Medical Officer since 2013

MD from Université de Montréal

Mélanie La Couture

Montreal Heart Institute

Chief Executive Officer since 2013

MBA from University of Western Ontario, Engineering degree from Polytechnique Montréal

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Robotic navigation for pulmonary venous antra isolation (PVAI) in 22 patients resulted in significantly shorter procedure times and reduced radiation exposure compared to conventional methods, indicating improved efficiency and safety.

Both robotic and conventional techniques showed high efficacy, with 91% of patients in the robotic group and 81% in the conventional group remaining free from atrial fibrillation during follow-up periods of 5 and 9 months, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experience with robotic navigation for catheter ablation of paroxysmal atrial fibrillation. Kautzner, J., Peichl, P., Cihák, R., et al.[2009]

In a study of 509 patients with atrial fibrillation (AF), pulmonary vein antrum isolation (PVAI) as a primary ablation strategy achieved long-term sinus rhythm restoration in 58.3% of patients after multiple procedures, highlighting its efficacy.

While additional substrate modification slightly improved success rates to 62.5%, it also led to a higher incidence of left-sided atrial flutter or tachycardia, indicating a trade-off in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year efficacy of pulmonary vein antrum isolation as a primary ablation strategy for atrial fibrillation: a single-centre cohort study. Teunissen, C., Kassenberg, W., van der Heijden, JF., et al.[2017]

The implementation of a comprehensive radiation safety program during pulmonary vein antral isolation (PVAI) significantly reduced radiation exposure for both patients and operators, with patient peak skin dose decreasing by three to ten times.

Despite similar procedure and fluoroscopy times between groups, the safety program led to a lower dose area product and a significantly reduced lifetime cancer risk for patients, highlighting its effectiveness in enhancing safety during atrial fibrillation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a comprehensive safety program on radiation exposure during catheter ablation of atrial fibrillation: a prospective study. Lakkireddy, D., Nadzam, G., Verma, A., et al.[2018]

In a study of 29 patients with pre-excited atrial fibrillation (AF), pulmonary vein antrum isolation (PVAI) significantly reduced the recurrence rate of AF to 11% compared to 50% in the control group, indicating its effectiveness as a treatment.

The use of 3D electroanatomical mapping during the procedure allowed for successful ablation of accessory pathways without increasing the duration of the procedure or X-ray exposure, highlighting the safety and efficiency of PVAI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein antrum isolation of pre-excited atrial fibrillation. Feng, XF., Wang, QS., Sun, J., et al.[2013]

Using supraglottic airways (SGAs) during deep sedation for pulmonary vein antrum isolation (PVAI) significantly reduced the time taken to complete the procedure (Time β) and the X-ray exposure time compared to deep sedation without SGAs, indicating improved efficiency.

Patients receiving SGAs experienced fewer minor complications, such as nasal bleeding, and had no instances of hypoxia, suggesting that SGAs enhance safety during catheter ablation for atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical benefits of deep sedation with a supraglottic airway while monitoring the bispectral index during catheter ablation of atrial fibrillation. Hida, S., Takemoto, M., Masumoto, A., et al.[2020]

References

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

Clinical predictors of arrhythmia recurrences following pulmonary vein antrum isolation for atrial fibrillation: predicting arrhythmia recurrence post-PVAI. [2011]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Catheter ablation and thoracoscopic ablation in long persistent atrial fibrillation with large left atrium. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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]

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

Early experience with robotic navigation for catheter ablation of paroxysmal atrial fibrillation. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Five-year efficacy of pulmonary vein antrum isolation as a primary ablation strategy for atrial fibrillation: a single-centre cohort study. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of a comprehensive safety program on radiation exposure during catheter ablation of atrial fibrillation: a prospective study. [2018]

7. China pubmed.ncbi.nlm.nih.gov

Pulmonary vein antrum isolation of pre-excited atrial fibrillation. [2013]

8. Japan pubmed.ncbi.nlm.nih.gov

Clinical benefits of deep sedation with a supraglottic airway while monitoring the bispectral index during catheter ablation of atrial fibrillation. [2020]