Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-02-23

Brief Summary

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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.

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multi-center, prospective outcomes registry

The study is a multi-center, prospective outcomes registry

Group Type OTHER

Esophageal Temperature-Guided Ablation

Intervention Type PROCEDURE

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.

Interventions

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Esophageal Temperature-Guided Ablation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No