Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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
-----------------
Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Esophageal Temperature-Guided Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multi-center, prospective outcomes registry<br>The study is a multi-center, prospective outcomes registry | Procedure: Esophageal Temperature-Guided Ablation<br>* Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature Decline | I. 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 procedure. | 90 days or when complications resolve | 
| Measurements of esophagus to each pulmonary vein | II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively. | 90 days or when complications resolve | 
| Create Recommendations for esophageal temperature-guided ablation | 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 | 90 days or when complications resolve | 
| Assessment of additional Adverse Events | To associate the development of symptoms (including dysphagia, chest pain, fever, heartburn, or odynophagia) with the presence of ulcerations. | 90 days or when complications resolve | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection on Phrenic Injury | Assess participants with abnormal imaging and/or adverse events that are related to the treatment. | 90 days or when complications resolve | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryoballoon Pulmonary Vein Isolation, Esophageal Effects