Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Study Overview
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Brief Summary
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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.

Official Title
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Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Periods of Apnea
* Other: Control Arm - No Periods of Apnea


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apnea<br>Patients will undergo an atrial fibrillation ablation and will have induced periods of apnea throughout the procedure. | Other: Periods of Apnea<br>* Periods of apnea throughout atrial fibrillation ablation.<br>|
| Active Comparator: Control<br>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. | Other: Control Arm - No Periods of Apnea<br>* Standard of care atrial fibrillation ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| Catheter Stability Metrics as measured by maximum and minimum contact force. | Maximum contact force: range between 0 and 60 grams | Day 1 | 
| Catheter Stability Metrics as measured by average contact force. | Average contact force: range between 0 and 60 grams | Day 1 | 
| Catheter Stability Metrics as measured by catheter displacement. | Catheter displacement (mean): range 0-10 mm | Day 1 | 
| Efficacy as measured by time to pulmonary vein isolation. | Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes | Day 1 | 
| Efficacy as measured by percentage of veins isolated after first pass. | Percentage of veins isolated after first pass: 0-100% | 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 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | End of study (12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Radiofrequency Ablation, Ablation, Arrhythmia