Catheter Ablation for Atrial Fibrillation

(STARAF3 Trial)

Not currently recruiting at 37 trial locations

Overseen By Caroline 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

Disqualifiers: Paroxysmal AF, Early persistent AF, Very long persistent AF, CHA2DS2-VASc score 0, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three methods best treats persistent atrial fibrillation (AF), a type of irregular heartbeat. The study will test three strategies: one focuses solely on isolating the pulmonary vein (Wide Circumferential Pulmonary Vein Antrum Isolation, PVAI), another adds targeting specific areas that might cause AF (Pulmonary Vein Antrum Isolation Plus Driver Ablation, PVAI+drivers), and a third includes isolating part of the heart's back wall (Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall, PVAI+box). Individuals with persistent AF for more than three months but less than three years, who experience symptoms like palpitations or shortness of breath and have not responded to at least one medication, might be suitable candidates. Participants will undergo one of these ablation procedures, which use advanced tools to improve treatment outcomes. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance future treatment options for atrial fibrillation.

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 prior data suggests that these ablation strategies are safe for patients with atrial fibrillation?

Research shows that the three ablation methods compared in this study—PV antral isolation alone (PVAI), PV antral isolation plus ablation of drivers (PVAI+drivers), and PV antral isolation plus isolation of the posterior wall (PVAI+box)—have been tested for safety in people.

Studies have found PVAI alone to be generally safe. Long-term follow-up reports indicate that this procedure is a standard and well-tolerated way to treat atrial fibrillation (AF).

The PVAI+drivers method is also considered safe and effective. Research involving many patients shows it has a good safety record and is widely used to improve success rates in AF treatment.

A review of 11 studies with over 1,600 patients found that the PVAI+box approach did not significantly increase adverse events compared to other methods. This suggests that adding posterior wall isolation does not raise safety concerns.

Overall, these treatments are generally well-tolerated. Past studies have shown no major differences in adverse events among these methods, indicating they are safe for use in AF treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for atrial fibrillation because they offer innovative ways to isolate problematic areas of the heart. Unlike traditional catheter ablation, which typically focuses on isolating the pulmonary veins, these treatments explore additional strategies. PVAI+box targets the posterior wall of the left atrium, potentially increasing effectiveness by addressing more than just the pulmonary veins. PVAI+drivers, on the other hand, involves ablation of specific cardiac drivers, which may be the key sources triggering atrial fibrillation. By expanding the scope of ablation beyond standard techniques, these methods aim to improve success rates and reduce recurrence of arrhythmias.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation?

Research has shown that isolating the pulmonary vein area (PVAI) effectively treats atrial fibrillation (AF), especially with a wide area approach. This method can reduce episodes of irregular heartbeats. In this trial, participants may receive PVAI alone or be assigned additional treatments. One option involves adding isolation of the back wall of the heart (PVAI+box), which has yielded mixed results; some studies find it beneficial, while others see little difference. Another option is adding driver ablation (PVAI+drivers), targeting areas that trigger AF, which has shown promise in improving outcomes. Overall, each method has strengths, but wider antral isolation generally proves more effective for long-term freedom from irregular heart rhythms. ^{1 3 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

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 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)

What Are the Treatments Tested in This Trial?

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 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.

How Is the Trial Designed?

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)

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

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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In this review, we will examine the mechanistic role of the posterior left atrium, discuss the technical challenges of ablating in the posterior wall.

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The addition of PWI and selective CFAE ablation to PVI significantly improves 12-month arrhythmia-free survival compared to PVI alone.

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The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical ...

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The Safety and Efficacy of Left Atrial BOX Ablation in ...

This meta-analysis assesses the safety and efficacy of adjunctive left atrial BOX ablation in treating persistent atrial fibrillation.