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出境医 / 临床实验 / Cryoballoon and Associated Esophageal Effects

Cryoballoon and Associated Esophageal Effects

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Ablation with cryoenergy Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)
Actual Study Start Date : November 25, 2015
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018
Arms and Interventions
Arm Intervention/treatment
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. 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.
 Procedure: Ablation with cryoenergy
Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.
Other Name: esophageal temperature-guided ablation
Outcome Measures
Primary Outcome Measures :
  1. Rate of temperature decline [ Time Frame: Up to 3 years ]
    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

  2. Associate the development of symptoms [ Time Frame: Up to 3 years ]
    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 :
  1. Phrenic nerve injury [ Time Frame: Up to 3 years ]
    To collect data phrenic nerve injury assessed with patient symptom questionnaire

  2. Post procedure symptoms [ Time Frame: Up to 3 years ]
    To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE November 25, 2015
Actual Primary Completion Date May 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Rate of temperature decline [ Time Frame: Up to 3 years ]
    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 [ Time Frame: Up to 3 years ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Phrenic nerve injury [ Time Frame: Up to 3 years ]
    To collect data phrenic nerve injury assessed with patient symptom questionnaire
  • Post procedure symptoms [ Time Frame: Up to 3 years ]
    To collect data regarding post-procedure symptoms including but not limited to cough, hemoptysis, and pericardial effusion using a symptom questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoballoon and Associated Esophageal Effects
Official Title  ICMJE Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Procedure: Ablation with cryoenergy
Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.
Other Name: esophageal temperature-guided ablation
Study Arms  ICMJE 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. 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: Procedure: Ablation with cryoenergy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2019) 		2
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2, 2018
Actual Primary Completion Date May 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960346
Other Study ID Numbers  ICMJE 015-238
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE Medtronic
Investigators  ICMJE Not Provided
PRS Account Baylor Research Institute
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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