Radiofrequency Ablation Under Apnea for Atrial Fibrillation

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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to assess the effect of apnea (breath hold) during atrial fibrillation (AF) ablation by having all ablations performed under apnea. By prospectively studying the effects of apnea on AF ablation, the investigators wish to demonstrate its feasibility, safety and impact on patient outcomes. This is a prospective study that includes both an apnea arm and a control arm. The subjects who consent to the apnea arm will undergo an atrial fibrillation ablation with periods of apnea. The subjects who consent to the control arm will agree to have their data from their standard of care atrial fibrillation be collected for comparison.

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.

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

Research shows that radiofrequency ablation (RFA) is effective in treating benign thyroid nodules, suggesting it may also be beneficial for other conditions like atrial fibrillation. RFA is a procedure that uses heat to destroy tissue, and its success in thyroid treatments indicates potential for effectiveness in similar applications. ^{1 2 3 4 5}

Is radiofrequency ablation generally safe for humans?

The research articles provided do not contain specific safety data for radiofrequency ablation in humans, focusing instead on its effects on conditions like sleep apnea and atrial fibrillation. ^{6 7 8 9 10}

How is the treatment 'Radiofrequency Ablation Under Apnea for Atrial Fibrillation' different from other treatments for atrial fibrillation?

This treatment is unique because it combines radiofrequency ablation (a procedure that uses heat to destroy abnormal heart tissue) with apnea (a temporary pause in breathing) to potentially improve the precision and effectiveness of the procedure by minimizing movement caused by breathing. ^{6 11 12 13 14}

Research Team

Jim Cheung, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

I am between 18 and 80 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Radiofrequency ablation for treatment of benign thyroid nodules: systematic review. [2022]

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

Successful radiofrequency ablation strategies for benign thyroid nodules. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Differences in the ultrasonographic appearance of thyroid nodules after radiofrequency ablation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided radiofrequency ablation (RFA) of benign symptomatic thyroid nodules - initial UK experience. [2022]

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

Radiofrequency ablation of benign symptomatic thyroid nodules: prospective safety and efficacy study. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation of persistent atrial fibrillation decreases a sleep-disordered breathing parameter during a short follow-up period. [2019]

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

Body mass index, obstructive sleep apnea, and outcomes of catheter ablation of atrial fibrillation. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Occult obstructive sleep apnea and clinical outcomes of radiofrequency catheter ablation in patients with atrial fibrillation. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Predictive value of obstructive sleep apnoea assessed by the Berlin Questionnaire for outcomes after the catheter ablation of atrial fibrillation. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure therapy might be an effective strategy on reduction of atrial fibrillation recurrence after ablation in patients with obstructive sleep apnea: insights from the pooled studies. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Esophageal pressure monitoring for airway management during catheter ablation of atrial fibrillation. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Impact of respiration gating on image integration guided atrial fibrillation ablation. [2021]

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

Complications of radiofrequency ablation in the treatment of sleep-disordered breathing. [2017]

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

Office-Based Multilevel Radiofrequency Ablation for Mild-to-Moderate Obstructive Sleep Apnea. [2023]