← Back to Search

Behavioural Intervention

Radiofrequency Ablation Under Apnea for Atrial Fibrillation

N/A

Waitlist Available

Led By Jim Cheung, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic paroxysmal atrial fibrillation

Age 18 - 80 years old

Must not have

Significant chronic obstructive pulmonary disease (such as those requiring home oxygen)

Severe systolic dysfunction defined as left ventricular ejection fraction < 30%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether holding your breath during atrial fibrillation surgery is safe and improves outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from holding breath and risks associated with standard ablation procedures such as bleeding, infection, or heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience sudden, irregular heartbeats.

Select...

I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need home oxygen for my severe lung condition.

Select...

My heart's pumping ability is significantly reduced.

Select...

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

Select...

I have severe high blood pressure in the lungs.

Select...

I have a lung condition that is not cancer, like interstitial lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Catheter Stability Metrics as measured by average contact force.

Catheter Stability Metrics as measured by catheter displacement.

Catheter Stability Metrics as measured by contact force variability.

+4 more

Secondary study objectives

Atrial Fibrillation

Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.

Procedural time as measured by the length of time from start to end of procedure.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met