Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: Esophageal Temperature-Guided Ablation

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Multi-center, prospective outcomes registry; The study is a multi-center, prospective outcomes registry

Procedure: 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.

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

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): February 23, 2018
• Study Completion (Actual): February 23, 2018

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Cryoballoon Pulmonary Vein Isolation; Esophageal Effects
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PI1002BD