← 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

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 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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,247 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

423 Patients Enrolled for Atrial Fibrillation

Northwell HealthOTHER

458 Previous Clinical Trials

470,805 Total Patients Enrolled

4 Trials studying Atrial Fibrillation

437 Patients Enrolled for Atrial Fibrillation

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,400 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care centers are currently administering this experiment?

"At present, 6 distinct medical trial sites are recruiting patients for this study. Three of these locations can be found in Bay Shore, Manhasset and Queens; the other three centers are located elsewhere. If you choose to join the trial, it is recommended that you select a site close by so as to minimize travel requirements."

Answered by AI

Does the minimum age requirement for this trial extend beyond 18 years?

"In order to participate in this research, patients must be aged between 18 and 80. Additionally, there are 11 studies for those younger than the age of consent and 474 trials available for people aged 65 or older."

Answered by AI

Are there still vacancies available for those wishing to take part in this trial?

"According to records on clinicaltrials.gov, the enrollment period for this particular study has been closed since July 12th 2022. Initially announced on October 8th 2020, it was concluded at a later date. Despite its closure there are still 477 other studies that remain open to participants across the globe."

Answered by AI

Are there any qualifications for taking part in this research endeavor?

"This clinical trial is searching to enrol 128 participants who suffer from atrial fibrillation and are aged between 18 and 80. To be eligible, potential candidates must meet two criteria: Be in the specified age range; Display persistent symptoms of paroxysmal atrial fibrillation."

Answered by AI

What key outcomes are being sought from this research endeavor?

"The focus of this research project, which will be tracked over a period of 24 hours, is to evaluate the catheter stability metrics through maximum and minimum contact force. Secondary objectives include assessing clinical outcomes as reflected by recurrence rate for atrial fibrillation six months post-intervention; evaluating procedural time from start to finish; and analysing safety based on the number of patients who experience an adverse event."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiofrequency Ablation of Atrial Fibrillation Under Apnea

2020. "Radiofrequency Ablation of Atrial Fibrillation Under Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04170894.

All > Afib > Atrial Fibrillation