Radiofrequency Ablation for Atrial Fibrillation

Overseen By Peter Leo BS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohad Ziv

Disqualifiers: Heart failure, Ejection fraction, Ventricular tachycardia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day (procedure)

250 Participants Needed

Trial Summary

What is the purpose of this trial?

A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to , 2. an approach of pulmonary vein isolation (PVI) alone.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must have failed or been intolerant to at least one antiarrhythmic drug, it's possible that some medication changes might be necessary. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Radiofrequency Ablation for Atrial Fibrillation?

Research suggests that targeting low-voltage areas during catheter ablation can reduce the recurrence of atrial fibrillation, making it a promising strategy for treating persistent atrial fibrillation. ^{1 2 3 4 5}

Is radiofrequency ablation for atrial fibrillation generally safe for humans?

Radiofrequency ablation for atrial fibrillation is considered a safe treatment for heart rhythm problems, but it does carry some risks. Complications can occur, such as issues with blood vessels or the heart's structure, and these risks are higher compared to other heart procedures. However, improvements in techniques have reduced these risks over time. ^{6 7 8 9 10}

How is Low Voltage-Directed Catheter Ablation different from other treatments for atrial fibrillation?

Low Voltage-Directed Catheter Ablation is unique because it targets specific low-voltage areas in the heart, which may improve outcomes for patients with persistent atrial fibrillation by addressing areas that contribute to the arrhythmia, unlike standard ablation that primarily focuses on isolating the pulmonary veins. ^{2 3 11 12 13}

Research Team

Ohad Ziv, MD

Principal Investigator

MetroHealth System, Ohio

Eligibility Criteria

This trial is for adults aged 18-85 with non-paroxysmal atrial fibrillation who've had a bad reaction or no success with at least one antiarrhythmic drug and are scheduled for an AF ablation procedure. They must not have severe heart issues, recent strokes, or be pregnant, among other exclusions.

Inclusion Criteria

I am scheduled for a procedure to treat atrial fibrillation.

Able and willing to comply with all protocol visit requirements.

Signed Patient Informed Consent (ICF).

Exclusion Criteria

Significant congenital anomaly or medical condition that may affect the integrity of study data.

I have had treatment for a serious heart rhythm problem in the last 6 months.

A blood clot in the left atrium was seen in imaging within 4 weeks before the ablation procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PVI with or without additional low voltage-directed ablation

1 day (procedure)

1 visit (in-person)

Blinding Period

Post-ablation blanking period where antiarrhythmic medications can be used

3 months

Follow-up

Participants are monitored for arrhythmia recurrence and safety

12 months

Follow-up at 1, 3, 6, 9, and 12 months

Treatment Details

Interventions

• Low Voltage-Directed Catheter Ablation

Trial Overview The study compares two techniques to treat atrial fibrillation: one combines low voltage-directed ablation with pulmonary vein isolation (LD+PVI), while the other uses only pulmonary vein isolation (PVI).

Participant Groups

Group I: PVI+Total LT Atrial low voltage ablation Active Control 1 Intervention

PVI radiofrequency ablation along with ablation of areas of "low voltage" identified.

Group II: Pulmonary vein isolation (PVI) alone Active Control 1 Intervention

Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed..

Low Voltage-Directed Catheter Ablation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Low Voltage-Directed Catheter Ablation for:

• Atrial Fibrillation

Approved in European Union as Low Voltage-Directed Catheter Ablation for:

• Atrial Fibrillation

Approved in Canada as Low Voltage-Directed Catheter Ablation for:

• Atrial Fibrillation

Who Is Running the Clinical Trial?

Ohad Ziv

Lead Sponsor

Trials

1

Recruited

250+

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Findings from Research

In a study of 359 patients undergoing catheter ablation for atrial fibrillation, 14.2% were found to have low-voltage zones, which are areas in the heart associated with increased risk of AF recurrence.

Factors such as older age, female sex, dilated cardiomyopathy, hypertrophic cardiomyopathy, persistent AF, and larger left atrial volume were identified as predictors of low-voltage zones, suggesting these could help tailor ablation strategies for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-procedural predictors of left atrial low-voltage zones in patients undergoing catheter ablation of atrial fibrillation. Ikoma, T., Naruse, Y., Kaneko, Y., et al.[2022]

The ongoing COAST-AF trial is investigating whether adding atrial low voltage area (LVA) catheter ablation to pulmonary vein isolation (PVI) improves treatment success rates for patients with persistent atrial fibrillation (AF), with a primary outcome of atrial arrhythmia event rates over 18 months.

This multicenter, randomized controlled trial will also assess safety, quality of life, and healthcare resource utilization, providing comprehensive insights into the benefits and risks of this combined ablation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale. Nery, PB., Wells, GA., Verma, A., et al.[2022]

In a study of 33 patients undergoing catheter ablation for atrial fibrillation, significant reductions in left atrial (LA) size and function were observed, with LA volume decreasing by 15% and ejection fraction by 14% after the procedure.

The decrease in LA function was strongly correlated with the volume of scar tissue in the LA, suggesting that the extent of radiofrequency ablation may impact post-procedural risks, including thromboembolic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial function and scar after catheter ablation of atrial fibrillation. Wylie, JV., Peters, DC., Essebag, V., et al.[2016]

In a study of 30 patients with persistent atrial fibrillation (AF), it was found that electrogram amplitudes were significantly higher during sinus rhythm (SR) compared to AF, indicating that the electrical activity of the heart differs between these two states.

The presence of fractionated electrograms, which are associated with abnormal electrical activity, was more common during AF than during SR, suggesting that voltage mapping during AF may provide important insights into the underlying substrate for atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Left Atrial Voltage between Sinus Rhythm and Atrial Fibrillation in Association with Electrogram Waveform. Masuda, M., Fujita, M., Iida, O., et al.[2018]

Catheter ablation for atrial fibrillation (AF) is as safe for patients with reduced left ventricular ejection fraction (LVEF) as it is for healthier patients, with similar complication rates of 8.0% vs 6.9%.

While patients with reduced LVEF had a higher rate of atrial arrhythmia relapse within the first 12 months (58.0% vs 37.6%), this lower efficacy is likely influenced by other health issues rather than LVEF itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial fibrillation in patients with heart failure with reduced ejection fraction: Real world experience from six European centers. Providência, R., de Asmundis, C., Chun, J., et al.[2020]

In a study of 1,011 patients undergoing pulmonary vein radiofrequency catheter ablation for atrial fibrillation, the overall complication rate was 3.9%, indicating a relatively low incidence of early complications associated with this procedure.

No procedure-related deaths occurred, and while some complications like peripheral vascular issues and cardiac tamponade were noted, they were generally manageable, suggesting that the procedure is safe, especially compared to earlier years of AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Bertaglia, E., Zoppo, F., Tondo, C., et al.[2016]

In a study analyzing 14,875 atrial fibrillation ablation cases from 2015 to 2017, 7.2% of patients experienced complications, with a notable increase in complications over the years, particularly pericardial issues.

Key predictors of complications included older age, female gender, pulmonary hypertension, and chronic kidney disease, while hospitals with higher procedural volumes had lower complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. Wu, L., Narasimhan, B., Ho, KS., et al.[2022]

Catheter ablation using radiofrequency energy is a generally safe and accepted treatment for cardiac arrhythmias, but the risk-to-benefit ratio must be carefully considered, especially for non-life-threatening conditions like AV-nodal reentrant tachycardia and atrial fibrillation.

Despite advancements in ablation techniques, atrial fibrillation ablation still carries a higher risk of complications compared to other procedures, with potential serious issues such as pulmonary vein stenosis and atrio-esophageal fistula formation, largely due to the complexity of the technique and the need for extensive catheter manipulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of patients pre-, per- and postcatheter ablation procedures: how to minimize complications? Altmann, D., Hindricks, G., Arya, A., et al.[2011]

Radiofrequency ablation is becoming a recognized curative treatment for atrial fibrillation that does not respond to antiarrhythmic drugs, but it carries significant risks due to the complexity of the procedure.

The paper emphasizes the importance of understanding potential complications and prevention techniques to enhance the safety and success rates of catheter ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nightmares in atrial fibrillation ablation--identification, management, and prevention of complications in radiofrequency ablation of atrial fibrillation]. Martinek, M., Pürerfellner, H.[2021]

In a study of 71 patients undergoing their first catheter ablation for atrial fibrillation (AF) at a low-volume center, the one-year recurrence rates were comparable to those seen in high-volume centers, with 19.5% for paroxysmal AF and 23.8% for persistent AF.

The major periprocedural complication rate was low at 2.8%, indicating that catheter ablation for AF can be performed safely in low-volume centers using modern technologies, with outcomes similar to those achieved in more experienced facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation for atrial fibrillation in a low-volume center using contemporary technology. Tay, JCK., Cai, XJ., Lin, J., et al.[2022]

In a study of 43 patients with atrial fibrillation who underwent radiofrequency catheter ablation, significant reductions in left and right atrial volumes were observed, along with improvements in right atrial and right ventricular function after 15 months.

The procedure did not negatively affect left atrial function, and while there were improvements in atrial size and strain, the left ventricular ejection fraction remained stable, indicating that RFCA can enhance atrial function without harming overall left ventricular performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic assessment in patients with atrial fibrillation (AF) and normal systolic left ventricular function before and after catheter ablation: If AF begets AF, does pulmonary vein isolation terminate the vicious circle? Liżewska-Springer, A., Dąbrowska-Kugacka, A., Lewicka, E., et al.[2021]

In a study of 72 patients undergoing catheter ablation for atrial fibrillation, the use of a non-fluoroscopic navigation system significantly reduced fluoroscopy exposure (15.4 minutes vs. 21.3 minutes) and overall procedural time (52 minutes vs. 61 minutes) compared to traditional methods.

Both groups achieved similar success rates in being arrhythmia-free after the procedure, with 74% in the non-fluoroscopic group and 78% in the control group, indicating that the new navigation system is effective without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. Rotter, M., Takahashi, Y., Sanders, P., et al.[2022]

In a meta-analysis of four randomized studies involving 539 patients, targeting low-voltage areas (LVA) during catheter ablation significantly improved freedom from arrhythmia in patients with persistent atrial fibrillation (AF) compared to conventional ablation methods.

There were no significant differences in procedural time, ablation time, or periprocedural complications between the LVA-targeted group and the non-LVA group, indicating that the LVA approach is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-voltage area substrate modification for atrial fibrillation ablation: a systematic review and meta-analysis of clinical trials. Junarta, J., Siddiqui, MU., Riley, JM., et al.[2022]

References

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

Pre-procedural predictors of left atrial low-voltage zones in patients undergoing catheter ablation of atrial fibrillation. [2022]

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

Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale. [2022]

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

Left atrial function and scar after catheter ablation of atrial fibrillation. [2016]

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

Comparison of Left Atrial Voltage between Sinus Rhythm and Atrial Fibrillation in Association with Electrogram Waveform. [2018]

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

Catheter ablation of atrial fibrillation in patients with heart failure with reduced ejection fraction: Real world experience from six European centers. [2020]

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

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. [2016]

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

Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Management of patients pre-, per- and postcatheter ablation procedures: how to minimize complications? [2011]

9. Germany pubmed.ncbi.nlm.nih.gov

[Nightmares in atrial fibrillation ablation--identification, management, and prevention of complications in radiofrequency ablation of atrial fibrillation]. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Catheter ablation for atrial fibrillation in a low-volume center using contemporary technology. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

Echocardiographic assessment in patients with atrial fibrillation (AF) and normal systolic left ventricular function before and after catheter ablation: If AF begets AF, does pulmonary vein isolation terminate the vicious circle? [2021]

12. England pubmed.ncbi.nlm.nih.gov

Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Low-voltage area substrate modification for atrial fibrillation ablation: a systematic review and meta-analysis of clinical trials. [2022]