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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER
275 Previous Clinical Trials
80,417 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
423 Patients Enrolled for Atrial Fibrillation
Northwell HealthOTHER
461 Previous Clinical Trials
471,007 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
437 Patients Enrolled for Atrial Fibrillation
Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,015 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
1,766 Patients Enrolled for Atrial Fibrillation

Media Library

Apnea (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04170894 — N/A
Atrial Fibrillation Research Study Groups: Apnea, Control
Atrial Fibrillation Clinical Trial 2023: Apnea Highlights & Side Effects. Trial Name: NCT04170894 — N/A
Apnea (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04170894 — N/A
~28 spots leftby Jun 2025
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