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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Periods of apnea throughout atrial fibrillation ablation.
Standard of care atrial fibrillation ablation.
Southside Hospital
Bay Shore, New York, United States
North Shore Hospital
Manhasset, New York, United States
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Long Island Jewish Medical Center
Queens, New York, United States
Houston Methodist Hospital
Houston, Texas, United States
Catheter Stability Metrics as measured by contact force variability.
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.
Time frame: Day 1
Catheter Stability Metrics as measured by maximum and minimum contact force.
Maximum contact force: range between 0 and 60 grams
Time frame: Day 1
Catheter Stability Metrics as measured by average contact force.
Average contact force: range between 0 and 60 grams
Time frame: Day 1
Catheter Stability Metrics as measured by catheter displacement.
Catheter displacement (mean): range 0-10 mm
Time frame: Day 1
Efficacy as measured by time to pulmonary vein isolation.
Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes
Time frame: Day 1
Efficacy as measured by percentage of veins isolated after first pass.
Percentage of veins isolated after first pass: 0-100%
Time frame: Day 1
Catheter Stability Metrics as measured by time to impedance drop.
Time to 5 ohm and 10 ohm impedance drop: range 1 to 60 seconds
Time frame: Day 1
Procedural time as measured by the length of time from start to end of procedure.
Length of procedure time determined by time lapsed per report from start of procedure to end of procedure.
Time frame: Day 1
Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.
Percentage of subjects with atrial fibrillation on 5 day event monitor at 6 months post-intervention.
Time frame: month six
Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.
Percentage of subjects with atrial fibrillation on 5 day event monitor at 12 months post-intervention.
Time frame: month 12
Safety, as measured by number of subjects with at least one adverse event.
Adverse events will include any unfavorable and unintended sign, symptom, or disease temporally associated with the procedure.
Time frame: End of study (12 months)
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