Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Periods of Apnea; Other: Control Arm - No Periods of Apnea

• Registration Number: NCT04170894
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Study Start: 2020-10-08
• Primary Completion: 2022-03-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Age 18 - 80 years old.
• Symptomatic paroxysmal atrial fibrillation.

Exclusion Criteria

• Patients with persistent or permanent atrial fibrillation or prior atrial fibrillation ablation.
• Significant chronic obstructive pulmonary disease (such as those requiring home oxygen).
• Severe pulmonary hypertension.
• Other intrinsic lung pathology such as interstitial lung disease.
• Severe systolic dysfunction defined as left ventricular ejection fraction < 30%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apnea	Periods of Apnea	Patients will undergo an atrial fibrillation ablation and will have induced periods of apnea throughout the procedure.
Control	Control Arm - No Periods of Apnea	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.

Primary Outcome Measures

Name	Time	Method
Catheter Stability Metrics as measured by maximum and minimum contact force.	Day 1	Maximum contact force: range between 0 and 60 grams
Efficacy as measured by percentage of veins isolated after first pass.	Day 1	Percentage of veins isolated after first pass: 0-100%
Catheter Stability Metrics as measured by time to impedance drop.	Day 1	Time to 5 ohm and 10 ohm impedance drop: range 1 to 60 seconds
Catheter Stability Metrics as measured by contact force variability.	Day 1	Contact force variability: Catheter stability metrics will be calculated as standard deviations of contact forces measured during the course of reach ablation region. Contact forces and their standard deviations will range between 0 and 60 grams.
Catheter Stability Metrics as measured by average contact force.	Day 1	Average contact force: range between 0 and 60 grams
Catheter Stability Metrics as measured by catheter displacement.	Day 1	Catheter displacement (mean): range 0-10 mm
Efficacy as measured by time to pulmonary vein isolation.	Day 1	Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.	month six	Percentage of subjects with atrial fibrillation on 5 day event monitor at 6 months post-intervention.
Procedural time as measured by the length of time from start to end of procedure.	Day 1	Length of procedure time determined by time lapsed per report from start of procedure to end of procedure.
Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.	month 12	Percentage of subjects with atrial fibrillation on 5 day event monitor at 12 months post-intervention.
Safety, as measured by number of subjects with at least one adverse event.	End of study (12 months)	Adverse events will include any unfavorable and unintended sign, symptom, or disease temporally associated with the procedure.

Trial Locations

Locations (6)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

North Shore Hospital; 🇺🇸 Manhasset, New York, United States

Southside Hospital; 🇺🇸 Bay Shore, New York, United States

New York Presbyterian Hospital - Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Long Island Jewish Medical Center; 🇺🇸 Queens, New York, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States