Radiofrequency Ablation Under Apnea for Atrial Fibrillation

No longer recruiting at 5 trial locations

Overseen By Heather Glum, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Persistent AF, COPD, Pulmonary hypertension, others

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

Compensation: Varies

Number of Visits: 13

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating atrial fibrillation, a heart rhythm disorder, by using radiofrequency ablation. This procedure uses heat to destroy problem areas in the heart while the patient temporarily holds their breath. The goal is to determine if this breath-holding technique, called apnea, can improve the procedure's results and safety. Participants will either undergo the procedure with apnea or have their standard treatment data used for comparison. The study seeks individuals with paroxysmal atrial fibrillation, characterized by episodes of irregular heartbeats that come and go, who are experiencing symptoms. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for atrial fibrillation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that radiofrequency ablation for atrial fibrillation is generally well-tolerated. Studies have found this procedure safe and effective for improving atrial fibrillation symptoms. In one study with many patients, nearby areas like the esophagus or nerves, which are close to the heart, experienced little to no harm. Another study found that using high power for short periods did not increase the risk of complications compared to traditional methods.

These findings suggest that radiofrequency ablation, even with added periods of breath-holding, is safe for most patients. While researchers continue to study the breath-holding aspect, current evidence on the ablation procedure itself shows promising safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using radiofrequency ablation under apnea for atrial fibrillation because it introduces a new approach to improving procedural outcomes. Most existing treatments focus on standard catheter ablation techniques without apnea. By inducing periods of apnea during the procedure, this method aims to enhance the precision and effectiveness of the ablation process. This could potentially lead to better targeting of the heart tissue responsible for atrial fibrillation, offering improved results over traditional methods.

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

Research has shown that radiofrequency ablation effectively treats atrial fibrillation (AF), with studies finding that about 77.6% of patients achieve successful outcomes after just one treatment. In this trial, one group of participants will undergo radiofrequency ablation with induced periods of apnea, while another group will receive the procedure without apnea as a control. Early results from using apnea during the procedure are promising. This technique might enhance treatment effectiveness by stabilizing the heart, potentially leading to better results and fewer recurrences of AF. ^{4 5 6 7 8}

Who Is on the Research Team?

Jim Cheung, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with occasional symptoms of atrial fibrillation, a heart rhythm disorder. It's not suitable for those with severe lung or heart conditions, persistent atrial fibrillation, or who've had previous ablation treatments.

Inclusion Criteria

I experience sudden, irregular heartbeats.

Exclusion Criteria

I need home oxygen for my severe lung condition.

My heart's pumping ability is significantly reduced.

I have ongoing or had atrial fibrillation, or underwent a procedure to treat it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo atrial fibrillation ablation with or without apnea, depending on the arm they are assigned to

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recurrence of atrial fibrillation

12 months

Multiple visits (in-person and virtual) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Apnea
• Control Arm - No Periods of Apnea
• Radiofrequency Ablation

Trial Overview The study is testing the effect of holding one's breath (apnea) during a procedure to correct irregular heartbeat (ablation). Participants will either undergo this procedure with apnea periods or receive standard care without apnea for comparison.

How Is the Trial Designed?

Group I: Apnea Experimental Treatment 1 Intervention

Patients will undergo an atrial fibrillation ablation and will have induced periods of apnea throughout the procedure.

Group II: Control Active Control 1 Intervention

Patients who choose not to participate in the apnea arm will have the opportunity to consent to the control arm. These patients will undergo an atrial fibrillation ablation per standard of care without periods of apnea throughout the procedure. This data will be collected to use as a comparator to the apnea arm.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

The Methodist Hospital Research Institute

Collaborator

Trials

299

Recruited

82,500+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Published Research Related to This Trial

Ultrasound-guided radiofrequency ablation (RFA) effectively reduced the volume of benign thyroid nodules in 1000 patients, achieving over 50% volume reduction in 78.9% of predominantly solid and 78.2% of predominantly cystic lesions after the first treatment, indicating its efficacy across different nodule types.

The only significant factor associated with successful treatment was a smaller nodule volume (less than 4 mL), suggesting that RFA is particularly effective for smaller nodules and can be considered a primary treatment option for benign thyroid nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful radiofrequency ablation strategies for benign thyroid nodules. Lee, GM., You, JY., Kim, HY., et al.[2020]

Radiofrequency ablation (RFA) is an effective treatment for benign thyroid nodules, achieving an average volume reduction of 74.51% within one year based on a study of 116 patients with 137 nodules.

Pre-ablation ultrasound characteristics, particularly cyst composition, can help predict treatment success, and post-ablation ultrasound changes may lead to misinterpretation of nodules as potentially malignant, highlighting the need for careful follow-up imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the ultrasonographic appearance of thyroid nodules after radiofrequency ablation. Wu, MH., Chen, KY., Chen, A., et al.[2021]

In a study of 140 patients undergoing catheter ablation for atrial fibrillation, the use of a respiratory gating module significantly reduced total procedure times and fluoroscopy times, enhancing the efficiency of the procedure.

The respiratory gating also led to shorter ablation times without increasing the duration of RF applications or mapping times, suggesting it improves the overall effectiveness of the ablation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of respiration gating on image integration guided atrial fibrillation ablation. Özcan, EE., Szeplaki, G., Tahin, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11918750/

Global Research Progress on Radiofrequency Ablation in ... Initial results from hybrid ablation procedures have been promising, showing higher success rates and lower arrhythmia recurrence than catheter ...

2. escardio.org escardio.org/The-ESC/Press-Office/Press-releases/Pulsed-field-ablation-was-not-superior-to-radiofrequency-ablation-in-paroxysmal-atrial-fibrillation

Pulsed field ablation was not superior to radiofrequency ... The primary endpoint, single-procedure success at 12 months, was high and similar between the procedure types: 77.2% in the PFA group and 77.6% ...

3. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02372-5/fulltext

Pulsed-field vs cryoballoon vs radiofrequency ablation The purpose of this study was to compare the procedural and long-term outcomes in patients with persistent AF undergoing PVI using PFA, CBA, or RFA.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527125026670

Comparison of 30-day readmission and same ... Pulsed field ablation (PFA) for atrial fibrillation (AF) is noninferior to radiofrequency ablation (RFA) regarding efficacy. However, data on ...

5. academic.oup.com academic.oup.com/europace/article/27/5/euaf066/8099957

HIgh Power short duration radiofrequency ablation or ... With a 1-year event-free rate of 73.4% for HPSD, they found comparable efficacy and safety outcomes. In contrast to our trial, a 'moderate' HPSD ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40785371/

Ablation Index-Guided Radiofrequency Ablation for Atrial ... Ablation Index-Guided Radiofrequency Ablation for Atrial Fibrillation: An Updated Meta-Analysis on Its Procedural Efficacy and Safety Profiles.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772374724003612

Effectiveness and Safety of Pulsed Field Ablation in ... Recent evidence has shown that catheter ablation is a safe and effective rhythm control strategy for improving AF-related symptoms.

8. nature.com nature.com/articles/s41591-024-03114-3

Safety of pulsed field ablation in more than 17000 patients ... Pre-clinical studies demonstrated no (or little) damage to peri-atrial tissue such as the esophagus and phrenic nerve, and no PV stenosis. The ...