Cryoballoon and Associated Esophageal Effects

Study Overview
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Brief Summary
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The primary objectives are to determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively. To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include: Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations As well as to associate the development of symptoms (including dysphagia, chest pain, fever, heartburn, or odynophagia) with the presence of ulcerations.

Detailed Description
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When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.

Official Title
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Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Ablation with cryoenergy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation Age >18 years Planned AF cryoablation procedure Exclusion Criteria: LA diameter >55mm Severe LVH (LV wall ≥ 15mm) LA thrombus Decompensated heart failure Plans for left atrial ablation lesions beyond isolation of the pulmonary veins History of previous pulmonary vein isolation Inability to place esophageal temperature probe or TEE probe Previously documented phrenic nerve injury Known esophageal pathology (complete GI history worksheet)

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Esophageal Effects<br>To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. Esophageal temperature probe is used during cryoablation to measure temperatures and then a 4-7 days post procedure esophagoscopy is performed to evaluate the physical effects on the esophagus. | Procedure: Ablation with cryoenergy<br>* Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.<br>* Other names: esophageal temperature-guided ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of temperature decline | Compare the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation using a esotest probe esophageal temperature probe to record the esophageal temperatures | Up to 3 years | 
| Associate the development of symptoms | To associate the development of symptoms (including dysphagia, chest pain, fever, heartburn, or odynophagia) with the presence of ulcerations using a symptom questionnaire and visualize the esophagus 4-7 days post procedure via esophagoscopy | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phrenic nerve injury | To collect data phrenic nerve injury assessed with patient symptom questionnaire | Up to 3 years | 
| Post procedure symptoms | To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire | Up to 3 years |