Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Radiofrequency Ablation, Ablation, Arrhythmia
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.
Interventions
OTHERPeriods of Apnea
Periods of apnea throughout atrial fibrillation ablation.
OTHERControl Arm - No Periods of Apnea
Standard of care atrial fibrillation ablation.
Sponsors
Northwell Health
The Methodist Hospital Research Institute
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 maximum and minimum contact force. | Day 1 | Maximum contact force: range between 0 and 60 grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed