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Completed

NCT Number: NCT03960346

Cryoballoon and Associated Esophageal Effects

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ablation with cryoenergy

Procedure

Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.

Other names: esophageal temperature-guided ablation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Medtronic

Registry information

Official study title

Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects (Medtronic EGD)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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