Cryoballoon and Associated Esophageal Effects
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ablation with cryoenergy
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Esophageal Effects
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Phrenic nerve injury
To collect data phrenic nerve injury assessed with patient symptom questionnaire
Post procedure symptoms
To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire
Full Information
NCT ID
NCT03960346
First Posted
March 25, 2016
Last Updated
May 20, 2019
Sponsor
Baylor Research Institute
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03960346
Brief Title
Cryoballoon and Associated Esophageal Effects
Official Title
Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 25, 2015 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esophageal Effects
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ablation with cryoenergy
Other Intervention Name(s)
esophageal temperature-guided ablation
Intervention Description
Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.
Primary Outcome Measure Information:
Title
Rate of temperature decline
Description
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
Time Frame
Up to 3 years
Title
Associate the development of symptoms
Description
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
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Phrenic nerve injury
Description
To collect data phrenic nerve injury assessed with patient symptom questionnaire
Time Frame
Up to 3 years
Title
Post procedure symptoms
Description
To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
12. IPD Sharing Statement
Learn more about this trial
Cryoballoon and Associated Esophageal Effects
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