Radiofrequency Ablation Under Apnea for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byJim Cheung, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

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.

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.

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Treatment Details

Interventions

Apnea (Behavioural Intervention)
Control Arm - No Periods of Apnea (Behavioural Intervention)
Radiofrequency Ablation (Procedure)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: ApneaExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 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.