Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Esophageal Temperature-Guided Ablation

• Registration Number: NCT02998866
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-11-18
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-21
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
2. Age >18 years
3. Planned AF cryoablation procedure

Exclusion Criteria

1. LA diameter >55mm
2. Severe LVH (LV wall ≥ 15mm)
3. LA thrombus
4. Decompensated heart failure
5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
6. History of previous pulmonary vein isolation
7. Inability to place esophageal temperature probe or TEE probe
8. Previously documented phrenic nerve injury
9. Known esophageal pathology (complete GI history worksheet)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-center, prospective outcomes registry	Esophageal Temperature-Guided Ablation	The study is a multi-center, prospective outcomes registry

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Data collection on Phrenic Injury	90 days or when complications resolve	Assess participants with abnormal imaging and/or adverse events that are related to the treatment.