Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esophageal Temperature-Guided Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Cryoballoon Pulmonary Vein Isolation, Esophageal Effects
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
Multi-center, prospective outcomes registry
Arm Description
The study is a multi-center, prospective outcomes registry
Outcomes
Primary Outcome Measures
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.
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.
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
Assessment of additional Adverse Events
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
Secondary Outcome Measures
Data collection on Phrenic Injury
Assess participants with abnormal imaging and/or adverse events that are related to the treatment.
Full Information
NCT ID
NCT02998866
First Posted
November 18, 2016
Last Updated
February 17, 2021
Sponsor
Baylor Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02998866
Brief Title
Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects
Official Title
Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Cryoballoon Pulmonary Vein Isolation, Esophageal Effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-center, prospective outcomes registry
Arm Type
Other
Arm Description
The study is a multi-center, prospective outcomes registry
Intervention Type
Procedure
Intervention Name(s)
Esophageal Temperature-Guided Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Temperature Decline
Description
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.
Time Frame
90 days or when complications resolve
Title
Measurements of esophagus to each pulmonary vein
Description
II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
Time Frame
90 days or when complications resolve
Title
Create Recommendations for esophageal temperature-guided ablation
Description
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
Time Frame
90 days or when complications resolve
Title
Assessment of additional Adverse Events
Description
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
Time Frame
90 days or when complications resolve
Secondary Outcome Measure Information:
Title
Data collection on Phrenic Injury
Description
Assess participants with abnormal imaging and/or adverse events that are related to the treatment.
Time Frame
90 days or when complications resolve
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Deville, MD
Organizational Affiliation
The Heart Hospital Baylor of Plano
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects
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