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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for treating atrial fibrillation (AF), a heart rhythm disorder. It compares a new technique, Low Voltage-Directed Catheter Ablation, which targets specific heart areas with low electrical activity and isolates the pulmonary veins, to the standard method that isolates only the pulmonary veins. The aim is to determine which approach is more effective for individuals with ongoing AF not well-managed by at least one medication. Those with non-paroxysmal AF who have struggled with medication may be suitable candidates. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance treatment options for AF.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that low voltage-directed catheter ablation is generally safe for people with atrial fibrillation. Studies have examined the risks of this treatment and found few serious side effects. For example, one study assessed procedure-related problems and found they were uncommon.

The trial compares two methods: low voltage-directed ablation with pulmonary vein isolation (PVI) and PVI alone. Both have established safety records. Although specific study data for these treatments do not indicate major safety issues, both methods have been used safely in other studies with similar patients.

In summary, while no treatment is without risk, current research suggests that both methods in this trial are generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low voltage-directed catheter ablation for atrial fibrillation because it specifically targets areas of the heart with low electrical voltage, which may be more effective in preventing irregular heartbeats. Unlike traditional treatments that focus mainly on isolating the pulmonary veins, this method adds a layer of precision by also addressing abnormal heart tissue that contributes to atrial fibrillation. This dual approach could potentially offer better outcomes and reduce the likelihood of the condition returning, making it a promising advancement over current options.

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

Research has shown that low voltage-directed catheter ablation can help manage atrial fibrillation (AF), especially when combined with pulmonary vein isolation (PVI). In this trial, one group of participants will receive PVI alone, a common procedure that isolates parts of the heart that can trigger AF. Another group will receive PVI along with low voltage-directed ablation, targeting areas in the heart with unusual electrical signals to prevent AF from recurring. Studies have found that this combined approach might offer extra benefits in stopping AF episodes. ^{1 3 6 7 8}

Who Is on the Research Team?

Ohad Ziv, MD

Principal Investigator

MetroHealth System, Ohio

Are You a Good Fit for This Trial?

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

Able and willing to comply with all protocol visit requirements.

Signed Patient Informed Consent (ICF).

I am scheduled for a procedure to treat atrial fibrillation.

Exclusion Criteria

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

Active enrollment in another investigational study involving a drug or device.

Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12092238/

Low-voltage-area ablation for persistent atrial fibrillation Based on these findings, ablation guided by LVAs may reduce AF substrates, leading to the suppression of AF recurrence. Several clinical trials ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.125.014210

Efficacy of Low-Voltage-Area Ablation Is Enhanced in ... SUPPRESS-AF trial demonstrated that low-voltage-area (LVA) ablation showed no significant benefit overall in persistent atrial fibrillation with ...

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.993790/full

Efficacy of left atrial low-voltage area-guided catheter ... This study aimed to evaluate the efficacy of low-voltage area (LVA)-guided substrate modification catheter ablation in patients with atrial fibrillation (AF).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jce.16264

Predictors of low‐voltage zones in patients with persistent ... Left atrial low-voltage areas predict atrial fibrillation recurrence after catheter ablation in patients with paroxysmal atrial fibrillation.

5. nature.com nature.com/articles/s41591-025-03674-y.pdf

Low-voltage-area ablation for persistent atrial fibrillation The purpose of the present study was to explore the efficacy of LVA ablation in addition to. PVI in patients with persistent AF and the presence of LVAs.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/56/NCT03355456/Prot_SAP_000.pdf

Low Voltage-Directed Catheter Ablation for Atrial Fibrillation The safety endpoint is the incident of procedure related adverse events. The secondary endpoint is atrial arrhythmia burden and need for AAD for the study ...

7. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.969475/full

A systematic review and meta-analysis of the safety and ... This study has shown that LVAs could improve the risk of arrhythmia recurrence in AF patients after conventional ablation.

8. ahajournals.org ahajournals.org/doi/10.1161/circep.115.002962

Ablation of Persistent Atrial Fibrillation Targeting Low ... After a single procedure, the success rate of pulmonary vein isolation (PVI) is about 50% in patients with persistent AF versus 80% with ...